Summary of Clinical Data for IFU EN (Zenith Dissection Endovascular System) 1

Size: px
Start display at page:

Download "Summary of Clinical Data for IFU EN (Zenith Dissection Endovascular System) 1"

Transcription

1 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 1 The Zenith Dissection Endovsculr System is line extension to the Zenith fmily of endovsculr devices. The Dissection Endovsculr Grft is similr to other endovsculr grfts in the product line, but is designed specificlly for tretment of dissections, hving no brbs. Informtion from previous clinicl studies nd clinicl use of the Zenith endovsculr grfts provides foundtion for the expected clinicl performnce of the Dissection Endovsculr Grft, including plcement in neurysml ortic segments. The clinicl study of the Zenith Dissection Endovsculr System enrolled ptients with cute, complicted dissections nd included implnttion of the Dissection Endovsculr Grft nd the Dissection Stent. Dt from the clinicl study performed on use of Zenith Dissection Endovsculr System for the tretment of cute, complicted Type B ortic dissection re presented below. A. Study Design Ptients were treted between August 4, 2012 nd Jnury 15, The dtbse for this PMA reflected dt collected through Mrch 14, 2017 nd included 73 ptients (67 US, 6 Jpn). There were 22 investigtionl sites (21 US, 1 Jpn). This study ws prospective, nonrndomized, single-rm, multi-ntionl / multicenter clinicl study bsed on binomil distribution for hypothesis testing. Becuse cute, complicted dissections re life-thretening, the primry endpoint for the study ws the survivl rte t 30 dys. The performnce gol for this endpoint (79.4%) ws n djusted rte bsed on the survivl rte t 30 dys in the Society of Vsculr Surgery (SVS) dtset, which includes pooled dt from physicin-sponsored studies reported by the SVS Outcomes committee. Null Hypothesis: The survivl rte t 30 dys, πs(30), does not meet the performnce gol (79.4%). H0: πs(30) 79.4% Alternte Hypothesis: The survivl rte t 30 dys, πs(30), meets the performnce gol (79.4%). HA: πs(30) > 79.4%

2 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 2 There ws n dditionl hypothesis-driven sfety endpoint of freedom from Mjor Adverse Events (MAEs) t 30 dys. The performnce gol for this endpoint (51.2%) ws n djusted rte bsed on the rte of freedom from MAEs t 30 dys in the SVS dtset. Null Hypothesis: The freedom from MAE t 30 dys, πs(30), does not meet the performnce gol (51.2%). H0: πs(30) 51.2% Alternte Hypothesis: The freedom from MAE t 30 dys, πs(30), meets the performnce gol (51.2%). HA: πs(30) > 51.2% Forty ptients were necessry to ssess the primry hypothesis, under n expected 30-dy survivl rte of 94.9% (estimted from fesibility study conducted under G for previous design of the dissection grft nd stent), with one-sided exct binomil test, t type I error rte of nd power of 0.8. Sixty ptients were necessry to ssess the dditionl hypothesis-driven endpoint, under n expected rte of freedom from 30-dy MAE t 69.2% (estimted from fesibility study conducted under G for previous design of the dissection grft nd stent), with one-sided exct binomil test, t type I error rte of nd power of 0.8. A smple size of 67 ws initilly estblished to ccount for possible loss to follow-up. During the course of the study, the smple size ws incresed to 73 ptients in order to ccount for six previously enrolled US ptients who should hve been excluded from the study ccording to dditionl medicl exclusion criteri tht were implemented subsequent to enrollment initition (none of the six hd confirmed bsence of bowel necrosis t the time of enrollment). While the dt from ll 73 ptients enrolled in the study re reported (enrollment IDs for the six excluded ptients re itlicized nd indicted by footnotes where pplicble), the hypotheses were ssessed bsed on the 67 ptients enrolled ccording to the inclusion/exclusion criteri. All other endpoints were nlyzed descriptively. Even though the endpoints re t 30-dys, dt through 12-month post-procedure ws required nd hs been provided on ll surviving ptients. This provides informtion on the bility of the Dissection Endovsculr Grft to sel entry ters covered by the device nd the bility of the Dissection Stent to provide support to

3 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 3 delminted segments of ortic dissections distl to the Dissection Endovsculr Grft. An independent core lbortory nlyzed ll ptient imging. An independent clinicl events committee (CEC) djudicted t minimum ll ptient deths, conversions to open repir, rupture, Type A dissections, nd stroke. An independent dt sfety monitoring bord (DSMB) monitored the clinicl tril ccording to n estblished sfety monitoring pln. 1. Clinicl Inclusion nd Exclusion Criteri Enrollment in the study ws limited to ptients who hd n cute, complicted, Type B ortic dissection with t lest one of the following chrcteristics: Aortic rupture; or Brnch vessel obstruction/compromise resulting in mlperfusion Ptients were not permitted to enroll in the study if they met ny of the following exclusion criteri: Generl Exclusion Criteri Age < 18 yers (< 20 yers for Jpn); Other medicl condition (e.g., cncer, congestive hert filure) tht my cuse the ptient to be noncomplint with the Clinicl Investigtion Pln, confound the results, or is ssocited with limited life expectncy (i.e., less thn 2 yers); Pregnnt, brest-feeding, or plnning on becoming pregnnt within 60 months; Unwilling or unble to comply with the follow-up schedule; Inbility or refusl to give informed consent; or Simultneously prticipting in nother investigtive device or drug study. (The ptient must hve completed the primry endpoint of ny previous study t lest 30 dys prior to enrollment in this study.) Medicl Exclusion Criteri Suspicion of bowel necrosis (s determined by the implnting physicin bsed on imging observtions, peritonel signs, surgicl explortion, elevted serum lctte levels, nd/or cidosis) Americn Society of Anesthesiologist (ASA) risk clss V (i.e., moribund

4 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 4 ptient not expected to live 24 hours with or without opertion) Embolic stroke within the lst 14 dys prior to potentil enrollment in the study or hemorrhgic stroke within 30 dys prior to potentil enrollment in the study; Dignosed or suspected congenitl degenertive connective tissue disese (e.g., no Mrfn s or Ehler-Dnlos syndrome); Systemic infection (e.g., sepsis); Bleeding dithesis, uncorrectble cogulopthy, or refuses blood trnsfusion; Allergy to stinless steel, polyester, solder (tin, silver), polypropylene, nitinol, or gold; Untretble rection to contrst, which, in the opinion of the investigtor, cnnot be dequtely pre-medicted; Surgicl or endovsculr bdominl ortic neurysm (AAA) repir within 30 dys before or fter dissection repir; Previous plcement of thorcic endovsculr grft; Prior open repir involving descending thorcic ort including suprrenl ort nd/or rch; or Interventionl nd/or open surgicl procedures (unrelted to dissection) within 30 dys before or fter dissection repir. Antomicl Exclusion Criteri Dissection of ort proximl to left subclvin rtery (either primry entry ter or most proximl extent of dissection); Proximl stent-grft component: o Aortic rch rdius of curvture < 35 mm (if device deployed in the rch); o Proximl lnding zone length mesuring < 20 mm between the left common crotid rtery nd most proximl extent of dissection (covering left subclvin rtery is cceptble, except in ptients with dominnt vertebrl rtery off of the rch in the region of the subclvin or dominnt vertebrl off of the subclvin); o Proximl lnding zone dimeter for proximl stent-grft component < 20 mm or > 38 mm, mesured outer-wll to outerwll on sectionl imge or multiplnr reconstruction;

5 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 5 o Distl lnding zone dimeter for proximl stent-grft component < 20 mm (estimte bsed on trnsortic dimeter) or > 38 mm (estimte bsed on true lumen dimeter), mesured outer-wll to outer-wll on sectionl imge or multiplnr reconstruction; o Prohibitive clcifiction, occlusive disese, or ngultion in intended proximl lnding zone; o Circumferentil thrombus in region of intended proximl lnding zone; o Inbility to preserve the ntive left common crotid rtery nd celic rtery origins; Distl bre stent component: o Dimeter < 20 mm (estimte bsed on trnsortic dimeter) or > 38 mm (estimte bsed on true lumen dimeter) for ny segment of vessel into which deployment of bre stent device is intended, mesured outer-wll to outer-wll on sectionl imge or multiplnr reconstruction; o Prohibitive ngultion in segments of vessel into which deployment of bre stent device is intended (e.g., rdius of curvture < 35 mm, or loclized ngle > 45 degrees); Both ilic rteries hving prohibitive tortuosity, clcifiction, occlusive disese or rteril dimeter, mesured inner-wll to inner-wll on sectionl imge, tht re not conducive to plcement of the introducer sheth (use of ccess conduit permitted); or Aneurysm or ngultion in the distl thorcic ort tht would preclude dvncement of the introduction system. 2. Follow-up Schedule All ptients were scheduled to return for follow-up exmintions t 30 dys, 6 months, 12 months, nd then nnully through 5 yers postopertively. Preopertively, ptients underwent clinicl exm, blood test, nd CT scn, s lso shown in Tble 1. Postopertively, the objective prmeters mesured during the study bsed on CT included ssessment of the totl ortic, true lumen, nd flse lumen dimeters t multiple loctions, presence of nd sources for flse lumen flow, extent of flse lumen thrombosis, progression of dissection, brnch vessel ptency, nd device position nd integrity. Adverse events nd complictions were recorded t ll visits.

6 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 6 The key timepoints re shown below in Tble 1 s well s the tbles tht follow summrizing sfety nd effectiveness. Tble 1. Study follow-up schedule Preopertive Intropertive Postprocedure 30-dy (± 10 dys) 6-month (± 30 dys) 12-month (± 45 dys) 2-yer to 5-yer e Clinicl exm X X X X X X Blood tests X X X X X X f Contrst CT scn X X c,d X c X c X c Angiogrphy X b X Including tests to evlute kidney nd liver function. b Required only to resolve ny uncertinties in ntomicl mesurements necessry for grft sizing. c Trnsesophgel echocrdiogrphy (TEE) or non-contrst CT imging my be used for those ptients experiencing documented renl filure (egfr< 30) or who re otherwise unble to undergo contrst enhnced CT scn. d CT must be performed prior to hospitl dischrge. In cse of impired renl function t the time of dischrge, CT my be performed t 30 dys. e 2 yers (730 ± 60 dys), 3 yers (1095 ± 60 dys), 4 yers (1460 ± 90 dys), nd 5 yers (1825 ± 90 dys). f Required only for ptients with mlperfusion tht hs not stbilized. 3. Clinicl Endpoints With regrds to sfety nd effectiveness, the primry endpoint is the survivl rte t 30 dys. With regrds to sfety, n dditionl hypothesis-driven endpoint for the study ws freedom from mjor dverse events (MAEs) t 30 dys. MAEs were defined s the following: myocrdil infrction, chronic renl insufficiency/chronic renl filure requiring dilysis, bowel ischemi, stroke, prplegi or prpresis, nd prolonged (> 72 hours) ventiltory support. With regrds to success/filure criteri, the study would be considered successful if both performnce gols were met. Additionl (secondry) endpoints tht were evluted, not for the purpose of sttisticl inference, included chnges in ortic, true nd flse lumen size, presence of nd sources for flse lumen flow, extent of flse lumen thrombosis, progression of dissection, brnch vessel ptency, secondry interventions, nd device migrtion nd integrity.

7 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 7 B. Accountbility of PMA Cohort At the time of the dtbse lock, of 73 ptients enrolled in the PMA study, 94.5% (69) were vilble for 30-dy follow-up nd 78.1% (57) were vilble for 12- month follow-up, s there were 4 deths within 30 dys nd 9 deths s well s 3 ptients who withdrew from the study or becme lost to follow-up between the 30-dy nd 12-month visits. Tble 2 reports the follow-up vilbility through 12 months. Of the 73 ptients enrolled in the study, 79.5% (58) received t lest one Dissection Endovsculr Grft nd one Dissection Stent during the index procedure, while the remining 20.5% (15) received only Dissection Endovsculr Grft, not Dissection Stent. Although the study ws not powered to ssess for differences in outcomes bsed on the different component combintions (nmely the presence vs. bsence of Dissection Stent), the results were nlyzed nd reported seprtely for the following groups where pproprite: totl ptient popultion, cohort with Dissection Stent, nd cohort without Dissection Stent.

8 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 8 Follow-up Visit c Tble 2. Follow-up vilbility Ptients Eligible for Follow-up Percent of Dt Avilble (Site) Clinicl Assessment CT Size Increse in Stent-grft Adequte Imging to Assess the Prmeter (Core Lb) Size Increse in Dissection Stent b Entryflow in Thorcic Aort Entryflow in Migrtion Abdominl Aort Device Integrity Events Occurring Before Next Intervl Deth Conversion LTF/ WTHD Postopertive % 45.2% 45.2% 49.3% NA NA NA (73/73) (39/73) (33/73) (33/73) (36/73) dy % 76.8% % 75.4% NA NA NA (67/69) (53/69) (49/69) (47/69) (52/69) month % 83.6% 98.2% 84.6% 76.1% 70.1% 74.6% 83.6% (52/67) (56/67) (55/67) (44/52) (51/67) (47/67) (50/67) (56/67) month % 92.2% 84.8% 82.5% 78.9% 80.7% 86. (49/57) (51/57) (47/57) (39/46) (47/57) (45/57) (46/57) (49/57) LTF: lost-to-follow-up; WTHD: withdrwl. Per clinicl investigtion pln mendment , ptient is required to hve CT scn prior to dischrge unless the ptient hs renl issues; in this cse, the ptient will hve the CT scn completed t the 1-month visit. b Size increse in Dissection Stent ssessment only pplies to ptients who received Dissection Stent. c Follow-up visit windows s follows: 30 dys (± 10 dys), 6 months (180 ± 30 dys), 12 months (365 ± 45 dys). Not Due for Next Visit

9 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 9 C. Study Popultion Demogrphics nd Bseline Prmeters The demogrphics nd bseline prmeters of the study popultion re typicl for n cute, complicted Type B ortic dissection study performed in the US. The demogrphics, pre-existing comorbid medicl conditions, nd presenting complictions were compred between this study nd SVS dtset to support the use of the performnce gols bsed on the SVS dtset. Comprisons were lso mde between two ptient groups within the study; ptients who received nd ptients who did not receive Dissection Stent. Prtilly due to the smll number of ptients, few sttisticlly significnt differences were found when compring popultions, despite numericl differences. None of the differences were found to be cliniclly meningful with respect to supporting the performnce gols. Some of the differences in the ptient groups within the study popultion re likely ssocited with the greter percentge of ptients who did not receive the Dissection Stent hving been treted for rupture rther thn mlperfusion. Comprisons re not presented between the US nd Jpnese ptients s only 6 ptients were treted in Jpn. Four ptients presented with rupture, one ptient presented with rupture nd mlperfusion, nd one ptient presented with mlperfusion lone; none received the Dissection Stent. Demogrphics The demogrphics nd ptient chrcteristics re presented in Tble 3. Of the demogrphic nd ptient dt in the present study compred with tht of the SVS dtset, only the ethnicity/rce distribution ws significntly different (p = 0.046), which is not expected to be cliniclly significnt with respect to evluting the sfety nd effectiveness endpoints. Similrly, with the exception of the ethnicity distribution, the demogrphics ppered comprble between ptients who either received or did not receive Dissection Stent.

10 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 10 Tble 3. Demogrphics nd ptient chrcteristics Men ± SD (N, rnge) or Percent Ptients (number/totl number) Demogrphic Without Dissection Stent With Dissection Stent All Pivotl Ptients SVS Acute Ptients Age (yers) All ptients 65.1 ± 13.1 (15, 42-81) Gender Mle Femle Ethnicity/Rce White Hispnic or Ltino Blck or Africn Americn First Ntions b Asin 53.3% (8/15) 46.7% (7/15) 33.3% (5/15) 20. (3/15) 59.5 ± 10.1 (58, 34-77) 69. (40/58) 31. (18/58) 67.2% (39/58) 5.2% (3/58) 25.9% (15/58) 60.7 ± 10.9 (73, 34-81) 65.8% (48/73) 34.2% (25/73) 60.3% (44/73) 4.1% (3/73) 24.7% (18/73) 46.7% (7/15) 1.7% (1/58) 11. (8/73) Height (in) 64.4 ± ± ± 4.5 (15, ) (58, 59-76) (73, 59-76) Weight (lbs) ± ± ± 54.5 (15, ) (58, ) (73, ) Body mss index 28.4 ± ± ± 6.9 (BMI) (15, ) (57, ) (72, ) NC: not collected. Ethnicity/rce distribution difference ws significnt between the pivotl study nd SVS dtset (p = 0.046). b First Ntions includes Americn Indin/Alskn Ntive, nd Ntive Hwiin/Pcific Islnder ± 15.4 (85, ) 72.9% (62/85) 27.1% (23/85) 52.9% (45/85) 14.1% (12/85) 27.1% (23/85) 2.4% (2/85) 3.5% (3/85) NC NC NC Medicl History nd Comorbidities Medicl history nd comorbid conditions re presented in Tble 4. None of the differences in the medicl histories of ptients enrolled in the present study nd those recorded in the SVS dtset re sttisticlly significnt. A history of neurysm or dissection is the biggest difference in ptient groups within the study, being more prevlent in ptients tht did not receive Dissection Stent. Tble 4. Medicl history nd comorbid conditions Percent Ptients (number/totl number) Medicl History Without With All Pivotl Dissection Dissection Ptients Stent Stent Crdiovsculr Previous myocrdil infrction Previous symptomtic congestive hert filure Coronry rtery disese Crdic rrhythmi Vsculr Thromboembolic event Peripherl vsculr disese 13.3% (2/15) (0/15) 20. (3/15) 20. (3/15) 6.7% (1/15) 3.4% (2/58) 3.4% (2/58) 15.5% (9/58) 13.8% (8/58) 8.6% (5/58) 3.4% (2/58) 5.5% (4/73) 2.7% (2/73) 16.4% (12/73) 15.1% (11/73) 6.8% (5/73) 4.1% (3/73) SVS Acute Ptients 11.8% (10/85) 10.6% (9/85) NC 11.8% (10/85) NC 2.4% (2/85)

11 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 11 Medicl History Fmily history of neurysm or dissection Ptient history of neurysm or dissection Hypertension Previous thorcic surgery or thorcic trum Aortobronchil fistul Aortoesophgel fistul Bleeding dithesis or uncorrectble cogulopthy Crotid endrterectomy Dignosed or suspected congenitl degenertive collgen disese Pulmonry Chronic obstructive pulmonry disese Renl Chronic renl insufficiency or dilysis Endocrine Without Dissection Stent 60. (9/15) 100. (15/15) 26.7% (4/15) Percent Ptients (number/totl number) With All Pivotl Dissection Ptients Stent 6.9% (4/58) 22.4% (13/58) 82.8% (48/58) 10.3% (6/58) 5.5% (4/73) 30.1% (22/73) 86.3% (63/73) 13.7% (10/73) SVS Acute Ptients NC NC 83.5% (71/85) NC NC NC NC NC NC 40. (6/15) 15.5% (9/58) 20.5% (15/73) 10.6% (9/85) 6.7% (1/15) 8.6% (5/58) 8.2% (6/73) 7.1% (6/85) Dibetes 5.2% (3/58) 4.1% (3/73) 12.9%(11/85) Infectious disese Previous dignosis of sepsis NC Heptobiliry Liver disese 6.7% (1/15) 1.7% (1/58) 2.7% (2/73) (0/85) Neoplsms Cncer 20. (3/15) 8.6% (5/58) 11. (8/73) 9.4% (8/85) Neurologic Smoking NC: not collected. Stroke Prpresis Prlysis Trnsient ischemic ttck Pst Current Never 13.3% (2/15) 6.7% (1/15) 6.7% (1/15) 13.3% (2/15) 40. (6/15) 46.7% (7/15) 5.2% (3/58) 5.2% (3/58) 3.4% (2/58) 3.4% (2/58) 31. (18/58) 50. (29/58) 19. (11/58) 6.8% (5/73) 5.5% (4/73) 2.7% (2/73) 4.1% (3/73) 27.4% (20/73) 47.9% (35/73) 24.7% (18/73) NC 1.2% (1/85) 2.4% (2/85) (0/85) 37.3% (31/83) 31.8% (27/83) 30.1% (25/83) ASA Clssifiction Tble 5 reports the ASA clssifiction. The distribution of ASA physicl sttus clssifictions in the present study ws sttisticlly different from tht in the SVS dtset, with the SVS ptients hving more severe disese. However, due to the subjective nture of the ASA clssifiction, nd considering the similrities between the present study nd the SVS dtset for most other vribles, the difference is not considered cliniclly significnt with respect to estblishing the

12 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 12 performnce gols. The mjority of ptients were clss 4 in both the group with Dissection Stent nd group without Dissection Stent. Tble 5. ASA physicl sttus clssifiction Percent Ptients (number/totl number) ASA Clssifiction Without Dissection Stent With Dissection Stent Totl SVS Helthy ptient (1) Mild systemic disese (2) 20. (3/15) 5.2% (3/58) 8.2% (6/73) 2.4% (2/85) Severe systemic disese (3) 20. (3/15) 29.3% (17/58) 27.4% (20/73) 22.4% (19/85) Incpcitting systemic disese (4) 60. (9/15) 65.5% (38/58) 64.4% (47/73) 64.7% (55/85) Moribund ptient (5) 10.6% (9/85) ASA clssifiction distribution difference ws significnt between the present study nd the SVS dtset (p = 0.008). SVS-ISCVS Risk Score Tble 6 reports the Society for Vsculr Surgery/Interntionl Society for Crdiovsculr Surgery (SVS-ISCVS) risk score. The SVS-ISCVS risk scores were consistent with the preexisting comorbid conditions for the ptient popultion in the present study. Of the distribution of risk scores, ptients who received Dissection Stent were more likely to present with higher smoking risk scores nd higher renl sttus risk scores, leding to higher totl risk scores. SVS- ISCVS risk scores were not reported in the SVS dtset. Tble 6. SVS-ISCVS risk score clssifiction Percent Ptients (number/totl number) SVS-ISCVS Ctegory Without Dissection Stent With Dissection Stent Totl Dibetes risk score (15/15) 93.1% (54/58) 5.2% (3/58) 1.7% (1/58) 94.5% (69/73) 4.1% (3/73) 1.4% (1/73) Smoking risk score Hypertension risk score % (8/15) 6.7% (1/15) 33.3% (5/15) 6.7% (1/15) 6.7% (1/15) 33.3% (5/15) 20. (3/15) 40. (6/15) 34.5% (20/58) 12.1% (7/58) 32.8% (19/58) 20.7% (12/58) 13.8% (8/58) 20.7% (12/58) 32.8% (19/58) 32.8% (19/58) 38.4% (28/73) 11. (8/73) 32.9% (24/73) 17.8% (13/73) 12.3% (9/73) 23.3% (17/73) 30.1% (22/73) 34.2% (25/73)

13 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 13 SVS-ISCVS Ctegory Hyperlipidemi risk score Crdic sttus risk score Crotid disese risk score Renl sttus risk score Pulmonry sttus risk score Totl SVS-ISCVS risk score (men ± SD; N, rnge) Percent Ptients (number/totl number) Without Dissection With Dissection Stent Stent 53.3% (8/15) 13.3% (2/15) 33.3% (5/15) 86.7% (13/15) 13.3% (2/15) 93.3% (14/15) 6.7% (1/15) 93.3% (14/15) 6.7% (1/15) 80. (12/15) 6.7% (1/15) 13.3% (2/15) 56.9% (33/58) 12.1% (7/58) 1.7% (1/58) 29.3% (17/58) 89.7% (52/58) 1.7% (1/58) 6.9% (4/58) 1.7% (1/58) 94.8% (55/58) 3.4% (2/58) 1.7% (1/58) 62.1% (36/58) 31. (18/58) 5.2% (3/58) 1.7% (1/58) 73.7% (42/57) 17.5% (10/57) 5.3% (3/57) 3.5% (2/57) Totl 56.2% (41/73) 12.3% (9/73) 1.4% (1/73) 30.1% (22/73) 89. (65/73) 4.1% (3/73) 5.5% (4/73) 1.4% (1/73) 94.5% (69/73) 4.1% (3/73) (0/73) 1.4% (1/73) 68.5% (50/73) 26. (19/73) 4.1% (3/73) 1.4% (1/73) 75. (54/72) 15.3% (11/72) 4.2% (3/72) 5.6% (4/72) 4.7 ± 2.4 (15, 1-9) 5.5 ± 2.9 (58, 0-12) 5.4 ± 2.8 (73, 0-12) Presenting Complictions Presenting complictions reported by the site re presented in Tble 7. The percentge of ptients with rupture, mlperfusion, or rupture nd mlperfusion were comprble between the present study nd the SVS dtset, though the ptient popultion in the present study significntly more often presented with obstruction/compromise tht lso involved the gstrointestinl (p < 0.001) nd renl/urologic brnch vessels (p = 0.011). Ptients who presented with rupture were less likely to receive Dissection Stent thn ptients who presented with obstruction or compromise. Tble 7. Presenting complictions Percent Ptients (number/totl number) Compliction Without With Dissection Dissection Stent Stent Totl SVS Rupture 73.3% (11/15) 15.5% (9/58) 27.4% (20/73) 31.8% (27/85) Obstruction/compromise of brnch vessel 33.3% (5/15) 89.7% (52/58) 78.1% (57/73) 71.8% (61/85)

14 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 14 Compliction Gstrointestinl Renl/urologic Spinl cord Lower extremity Other Rupture nd obstruction of brnch vessel Percent Ptients (number/totl number) Without With Dissection Dissection Stent Stent Totl SVS 40. (2/5) 59.6% (31/52) 57.9% (33/57) 19.7% (12/61) 60. (3/5) 57.7% (30/52) 57.9% (33/57) 36.1% (22/61) 5.8% (3/52) 5.3% (3/57) 3.3% (2/61) 80. (4/5) 53.8% (28/52) 56.1% (32/57) 55.7% (34/61) 1.9% (1/52) 1.8% (1/57) 8.2% (5/61) 6.7% (1/15) 5.2% (3/58) 5.5% (4/73) 3.5% (3/85) Persistent pin 93.3% (14/15) 91.4% (53/58) 91.8% (67/73) 76.5% (65/85) Size/growth of the trnsortic dimeter 53.3% (8/15) 15.5% (9/58) 23.3% (17/73) NC Periortic effusion (without rupture) 60. (9/15) 12.1% (7/58) 21.9% (16/73) NC Resistnt hypertension 40. (6/15) 27.6% (16/58) 30.1% (22/73) 43.5% (37/85) NC: not collected. Persistent pin, gstrointestinl, nd renl/urologic obstruction/compromise of brnch vessel distribution differences were significnt between the present study nd the SVS dtset (p =0.010, p < 0.001, nd p = 0.011, respectively). Bseline Vessel Mesurements This section reports the results from core lbortory nlysis of pre-procedure imging. Site vs Core Lb Mesures Imging ws reviewed by the clinicl study sites to determine dherence to the study selection criteri. All ptients enrolled in the study were reported by the sites to meet the selection criteri. However, totl of 33 ptients were mesured by the core lbortory s hving length < 20 mm from the left common crotid (LCC) to the most proximl extent of dissection (Tble 8), 25 of which lso hd dissection tht extended proximl to the left subclvin rtery (LSA) ccording to initil ssessments reltive to ntomicl lndmrks (Tble 10) or bsed on the Zone clssifiction 1 s lso used to describe the extent of Dissection Endovsculr Grft nd Dissection Stent coverge t the time of the index procedure (Tble 18, found in the Procedurl Informtion Section). There were 11 dditionl ptients (in whom the length from LCC to proximl extent ws either not ssessed or mesured 20 mm by core lb) with dissection tht extended proximl the LSA bsed on the Zone clssifiction. Refer to Figure 1 for n overview of these findings.

15 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) Core Lb Mesures of Short necks nd proximl dissections (44 Pts with one or both) 33 Totl Pts Proximl length < 20 mm 36 Totl Pts Dissection tht extended proximl the LSA 8 pts Short neck only 11 pts Dissection tht extended proximl the LSA only 25 pts Short neck nd dissection tht extended proximl to the LSA Figure 1. Core lb mesurements of short necks nd/or dissection proximl to the LSA Also of note, the mximum totl ortic dimeters (Tble 8) in loctions expected to coincide with likely fixtion/sel zones (i.e., just distl to the LCC nd just distl to the LSA) exceeded the mximum llowble dimeter of 38 mm t preprocedure (n=14, which included 12 of the ptients with length < 20 mm from the LCC to proximl extent of dissection nd/or dissection tht extended proximl to the LSA). While ptients were to be excluded from the study if the length from the LCC to the most proximl extent of dissection ws < 20 mm, if the dissection extended proximl to the LSA, or if the totl ortic dimeter ws > 38 mm in the proximl fixtion zone, complince with the protocol ws bsed on informtion vilble t pre-procedure, s ssessed by the site, nd not the results from subsequent core lbortory nlysis of pre-procedure imging. All site ssessments concurred with the requirements in the protocol. Nonetheless, it is importnt to note tht ll proximl post-tretment dissection events (4/4), ruptures (2/2), nd proximl Type I entry-flow (7/7) within 365 dys occurred in this subset of ptients with ntomy beyond the intended use, underscoring the need to py creful ttention to these prmeters during ptient selection, s lso emphsized in the lbeling. Length nd Dimeter Tble 8 reports bseline ntomicl mesurements per the core lbortory (similr dt were not reported in the SVS dtset). The overll results from core lbortory nlysis of pre-procedure imging pper consistent with expecttions

16 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 16 for the intended study ptient popultion, nd the mjority of the ntomicl mesurements for ptients who received Dissection Stent nd for those who did not ppered comprble, with the exception of some dimeters nd lengths, s follows. With regrds to length, ptients who did not receive Dissection Stent (ptients who often presented with ortic rupture) typiclly exhibited more focl dissections (i.e., shorter length of dissected ort) when compred to ptients who received Dissection Stent (ptients who often presented with obstruction/compromise of brnch vessels). Additionlly, the verge length of dissection (408.9 mm) in ptients who received Dissection Stent pproched the totl length of ort from the left common crotid rtery to the ortic bifurction, thus indicting ner complete involvement of the ort with dissection. Overll, the trends in length were not surprising given the pprent difference in presenting complictions between groups. With regrds to dimeter, ptients who did not receive Dissection Stent were more likely to hve presented with lrger trnsortic dimeters in the descending thorcic ort, which is not surprising considering these ptients were more often treted for rupture when compred to the ptients who received Dissection Stent. Ptients who received Dissection Stent were more likely to disply lrger flse lumen dimeters in the ort distl to the descending thorcic ort, specificlly within the region of the brnch vessels (ort t the level of the celic rtery, SMA, nd both renl rteries) s well s in the bdominl ort, which is lso not surprising considering these ptients were more often treted for mlperfusion when compred to ptients who did not receive Dissection Stent.

17 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 17 Tble 8. Bseline ntomicl mesurements per the core lbortory Antomicl Mesurements Length (mm) LCC to most proximl extent of dissection Men ± SD (N, rnge) Without Dissection Stent With Dissection Stent Totl 26.8 ± 37.7 (13, to 118.4) 23.9 ± 38.8 (53, to 191.5) 24.5 ± 38.3 (66, to 191.5) LCC to most proximl spect of primry ter 93.5 ± 56.8 (11, ) ± 69.4 (48, ) ± 67.2 (59, ) From most proximl to most distl spect of dissection Aortic rch rdius of curvture (mm) Lrgest ngle in the descending thorcic ort (degrees) ± (13, ) ± (40, ) ± (53, ) 26.6 ± 4.9 (15, 19-40) 28.2 ± 7.0 (56, 13-47) 27.8 ± 6.6 (71, 13-47) 32.7 ± 27.1 (14, 0-99) 31.1 ± 26.6 (55, 0-175) 31.4 ± 26.5 (69, 0-175)

18 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 18 Antomicl Mesurements Mximum ortic dimeter (mm) Just distl to LCC origin True lumen Flse lumen Totl Just distl to LSA origin True lumen Flse lumen Totl Descending thorcic ort True lumen Flse lumen Totl Just distl to celic rtery origin True lumen Flse lumen Totl Just distl to SMA origin True lumen Flse lumen Totl Just distl to right renl rtery origin True lumen Flse lumen Totl Just distl to left renl rtery origin True lumen Flse lumen Totl Abdominl ort True lumen Flse lumen Totl Men ± SD (N, rnge) Without Dissection Stent With Dissection Stent Totl 32.0 ± 5.0 (15, ) 1.6 ± 4.9 (15, ) 33.6 ± 3.4 (15, ) 27.8 ± 6.8 (15, ) 6.1 ± 8.8 (15, ) 33.9 ± 6.2 (15, ) 25.4 ± 12.9 (15, ) 19.2 ± 12.0 (15, ) 44.6 ± 10.9 (15, ) 19.8 ± 8.7 (14, ) 10.0 ± 12.6 (14, ) 29.8 ± 8.6 (14, ) 19.2 ± 8.5 (14, ) 7.4 ± 10.0 (14, ) 26.6 ± 5.2 (14, ) 17.4 ± 7.2 (14, ) 5.7 ± 7.6 (14, ) 23.2 ± 4.1 (14, ) 17.4 ± 7.6 (14, ) 5.9 ± 8.1 (14, ) 23.3 ± 4.6 (14, ) 25.0 ± 12.8 (14, ) 12.3 ± 12.5 (14, ) 37.3 ± 11.6 (14, ) 32.4 ± 4.3 (56, ) 0.6 ± 2.6 (56, ) 33.1 ± 4.1 (56, ) 27.9 ± 4.6 (56, ) 4.4 ± 4.9 (56, ) 32.3 ± 4.6 (56, ) 21.5 ± 10.0 (56, ) 18.2 ± 8.0 (56, ) 39.6 ± 5.7 (56, ) 14.3 ± 6.5 (55, ) 14.3 ± 6.4 (55, ) 28.6 ± 3.4 (55, ) 15.0 ± 6.6 (53, ) 12.2 ± 7.6 (53, ) 27.1 ± 3.7 (53, ) 14.9 ± 6.1 (52, ) 9.7 ± 6.9 (52, ) 24.6 ± 3.7 (52, ) 14.5 ± 6.3 (53, ) 9.7 ± 8.0 (53, ) 24.2 ± 4.1 (53, ) 16.5 ± 7.7 (48, ) 16.1 ± 7.9 (48, ) 32.6 ± 4.9 (48, ) LCC: left common crotid rtery; LSA: left subclvin rtery; SMA: superior mesenteric rtery; CIA: common ilic rtery ± 4.4 (71, ) 0.8 ± 3.2 (71, ) 33.2 ± 3.9 (71, ) 27.9 ± 5.1 (71, ) 4.8 ± 5.9 (71, ) 32.6 ± 5.0 (71, ) 22.3 ± 10.7 (71, ) 18.4 ± 8.9 (71, ) 40.7 ± 7.3 (71, ) 15.5 ± 7.2 (69, ) 13.4 ± 8.1 (69, ) 28.9 ± 4.9 (69, ) 15.8 ± 7.2 (67, ) 11.2 ± 8.3 (67, ) 27.0 ± 4.1 (67, ) 15.4 ± 6.3 (66, ) 8.9 ± 7.2 (66, ) 24.3 ± 3.8 (66, ) 15.1 ± 6.6 (67, ) 8.9 ± 8.1 (67, ) 24.0 ± 4.2 (67, ) 18.4 ± 9.7 (62, ) 15.3 ± 9.2 (62, ) 33.6 ± 7.2 (62, )

19 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 19 Loction of Primry Ter Tble 9 reports the loction of the primry ter s ssessed by the core lbortory. As expected for study of ptients with Type B dissection, the mjority of primry ters for the totl ptient popultion occurred in the descending thorcic ort. The distribution in primry ter loction ppered to be similr for both ptient popultions bsed on core lbortory nlysis. Tble 9. Loction of primry ter per the core lbortory Percent Ptients (number/totl number) Loction Without Dissection With Dissection Stent Stent Totl Aort t LSA/in LSA 1.8% (1/57) 1.4% (1/72) Descending thorcic ort, distl to LSA 86.7% (13/15) 86. (49/57) 86.1% (62/72) Aort t celic rtery/in celic rtery Aort t SMA/in SMA Aort t renl rteries/in renl rteries Infrrenl bdominl ort Unknown 13.3% (2/15) 12.3% (7/57) 12.5% (9/72) LCC: left common crotid rtery; LSA: left subclvin rtery; SMA: superior mesenteric rtery. Ptient ws unble to be ssessed by the core lbortory due to indequte imging. Loction of Proximl Extent of Dissection Tble 10 provides the distribution of the loction of the proximl spect of dissection s determined by the core lbortory. The mjority of the totl ptient popultion hd the proximl spect of dissection either t or distl to the LSA, while some ptients were noted by the core lbortory to hve dissection with the most proximl spect in the scending ort, ortic rch (proximl to the LCC), or proximl to the LSA (distl to the LCC). Likewise, the mjority of ptients in both groups hd the proximl spect of the dissection either t or distl to the LSA. Tble 10. Loction of the proximl spect of dissection s determined by the core lbortory Percent Ptients (number/totl number) Loction Without Dissection With Dissection Stent Stent Totl Ascending thorcic ort 3.5% (2/57) 2.8% (2/72) Aortic rch, proximl to LCC 20. (3/15) 1.8% (1/57) 5.6% (4/72) Proximl to LSA, distl to LCC 6.7% (1/15) 10.5% (6/57) 9.7% (7/72) Aort t LSA/in LSA 20. (3/15) 50.9% (29/57) 44.4% (32/72)

20 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 20 Percent Ptients (number/totl number) Loction Without Dissection With Dissection Stent Stent Totl Descending thorcic ort, distl to LSA 53.3% (8/15) 31.6% (18/57) 36.1% (26/72) Aort t celic rtery/in celic rtery Aort t SMA/in SMA Aort t renl rteries Infrrenl bdominl ort Unknown 1.8% (1/57) 1.4% (1/72) LCC: left common crotid rtery; LSA: left subclvin rtery; SMA: superior mesenteric rtery. Ptient ws unble to be ssessed by the core lbortory due to indequte imging. Loction of Distl Extent of Dissection Tble 11 provides the distribution of the loction of the distl spect of dissection s determined by the core lbortory. The dissection often extended distlly to t lest the level of the celic rtery, with the mjority of dissections for the totl ptient popultion terminting distl to the renl rteries, in either the bdominl ort or common/externl ilic rteries. Compred to the ptients who did not receive Dissection Stent, those ptients who did receive Dissection Stent ppered to more often hve dissection tht terminted in the externl ilic rteries. Tble 11. Loction of the most distl spect of dissection s determined by the core lbortory Percent Ptients (number/totl number) Loction Without Dissection With Dissection Stent Stent b Totl Aort t celic rtery/in celic rtery 8.3% (1/12) 1.5% (1/68) Aort t SMA/in SMA 16.7% (2/12) 3.6% (2/56) 5.9% (4/68) Aort t renl rteries/in renl rteries 8.3% (1/12) 12.5% (7/56) 11.8% (8/68) Infrrenl bdominl ort 25. (3/12) 19.6% (11/56) 20.6% (14/68) Common ilic rteries (right or left) 25. (3/12) 17.9% (10/56) 19.1% (13/68) Externl ilic rteries (right or left) 28.6% (16/56) 23.5% (16/68) Internl ilic rteries (right or left) 1.8% (1/56) 1.5% (1/68) Femorl rteries (right or left) Unknown 16.7% (2/12) 16.1% (9/56) 16.2% (11/68) SMA: superior mesenteric rtery. Ptients , , nd were unble to be ssessed by the core lbortory due to indequte imging. b Ptients nd were unble to be ssessed by the core lbortory due to indequte imging.

21 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 21 Secondry Ters Tble 12 provides the distribution of the loction of the identified secondry/reentry ters s determined by the core lbortory. The mjority of the totl ptient popultion presented with secondry ters, often in the descending thorcic ort s well s in the bdominl ort nd t/ner the renl rteries. While most ptients in both groups hd secondry ters in the descending thorcic ort, it ppered tht ptients who received Dissection Stent hd higher prevlence of secondry ters in the region of the brnch vessels (renl rteries, SMA, celic rtery), bdominl ort, nd ilic rteries. Tble 12. Loction of the secondry/reentry ters s determined by the core lbortory Percent Ptients (number/totl number) Loction Without Dissection With Dissection Stent Stent b Totl None 13.3% (2/15) 3.5% (2/57) 5.6% (4/72) Ascending thorcic ort Aortic rch, proximl to LCC Proximl to LSA, distl to LCC Aort t LSA/in LSA Descending thorcic ort, distl to LSA 80. (12/15) 84.2% (48/57) 83.3% (60/72) Aort t celic rtery/in celic rtery 6.7% (1/15) 28.1% (16/57) 23.6% (17/72) Aort t SMA/in SMA (0/15) 28.1% (16/57) 22.2% (16/72) Aort t renl rteries/in renl rteries 13.3% (2/15) 43.9% (25/57) 37.5% (27/72) Infrrenl bdominl ort 13.3% (2/15) 49.1% (28/57) 41.7% (30/72) Common ilic rteries (right or left) 17.5% (10/57) 13.9% (10/72) Externl ilic rteries (right or left) 3.5% (2/57) 2.8% (2/72) Internl ilic rteries (right or left) 1.8% (1/57) 1.4% (1/72) Femorl rteries (right or left) Unknown 6.7% (1/15) 10.5% (6/57) 9.7% (7/72) LCC: left common crotid rtery; SLA: left subclvin rtery; SMA: superior mesenteric rtery. Ptients my hve presented with multiple secondry/reentry ters. b Ptient ws unble to be ssessed by the core lbortory due to indequte imging. Procedurl Informtion Procedurl informtion is summrized in Tble 13. All procedures were performed under generl nesthesi. Vsculr ccess techniques employed during the procedure included femorl rtery cutdown in 72.6% of ptients, percutneous ccess in 58.9% of ptients, nd use of conduit in 2.7% of ptients (multiple ccess methods were possible). A surgicl cutdown ppered more common in ptients without Dissection Stent. Adjunctive techniques for spinl cord protection were performed in 39.7%, including primrily cerebrospinl fluid (CSF) dringe. The

22 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 22 mjority of ptients hd either prtil of complete coverge of the left subclvin rtery (LSA), often without revsculriztion procedure. Tble 13. Procedurl informtion Item Result n (%) Anesthesi Method Generl 73 (10) Regionl 0 Locl 0 Access Method Percutneous 43 (58.9%) Cut-Down 53 (72.6%) Conduit 2 (2.7%) Adjunctive Techniques to Prevent Prplegi CSF Dringe 26 (35.6%) Neurologic/Cerebrl Monitoring 2 (2.7%) Induced Hypertension 1 (1.4%) LSA Coverge Complete 28 (38.4%) Prtil 15 (20.5%) None 30 (41.1%) LSA Revsculriztion Procedure None 58 (79.4%) Trnsposed 4 (5.5%) Bypssed 11 (15.1%) Multiple ccess methods my hve been used in ptient. The men procedure time ws ± 91.3 minutes nd the men procedurl blood loss ws 242 ± 316 ml. The men nesthesi time ws 234 ± 97 minutes. Procedure times s well s procedurl blood loss ppered greter on verge in ptients who received Dissection Stent, which is resonbly expected given the differences between groups in terms of number of components plced, s further described below. Devices Plced during Index Procedure Tbles report the number nd sizes of Dissection Endovsculr Grfts (nontpered nd tpered) nd Dissection Endovsculr Stents plced t the time of the index procedure. The lrgest (42 mm) nd smllest (22 mm) dimeters, the longest (218 mm) nd shortest (79 mm) lengths, nd both tpered options (4 mm nd 8 mm) were used mong the ptients enrolled in the study, supporting the clinicl

23 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 23 relevnce of the vilble sizes. All vilble Dissection Stent dimeters nd lengths were used. Tble 14. Number nd sizes (dimeters nd lengths) of nontpered Dissection Endovsculr Grft components implnted during index procedure Dimeter (mm) Length (mm) N

24 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 24 Tble 15. Number nd sizes (dimeters nd lengths) of tpered Dissection Endovsculr Grft components implnted during index procedure Proximl Distl Length Dimeter Dimeter N (mm) (mm) (mm) Tble 16. Number nd sizes (dimeters nd lengths) of Dissection Stent components implnted during index procedure Dimeter (mm) Length (mm) N

25 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 25 Tble 17 further describes the different min body component combintions used during the initil implnt procedure, s selected t the discretion of the treting physicin, for ptients who did not receive Dissection Stent nd for ptients who received Dissection Stent. All ptients received t lest one stent-grft, with nerly 8 of ptients lso receiving t lest one Dissection Stent. Two or more Dissection Endovsculr Grfts were used in pproximtely one-third of ptients. There ppered to be differences between groups in terms of the number of components plced, where three or more components were plced in hlf of the ptients with Dissection Stent, wheres none of the ptients in the group without Dissection Stent received more thn two components (nd 4 received one component). Tble 17. Combintion of components plced during the initil implnt procedure Min Body Combintion Percent Ptients (number/totl number) Without Dissection Stent With Dissection Stent One Dissection Endovsculr Grft (only) 40. (6/15) NA Two Dissection Endovsculr Grfts (only) 60. (9/15) NA One Dissection Endovsculr Grft nd one Dissection Stent NA 44.8% (26/58) One Dissection Endovsculr Grft nd two Dissection Stents NA 22.4% (13/58) One Dissection Endovsculr Grft nd three Dissection NA 1.7% (1/58) Stents One Dissection Endovsculr Grft nd four Dissection Stents NA 1.7% (1/58) Two Dissection Endovsculr Grfts nd one Dissection Stent NA 24.1% (14/58) Two Dissection Endovsculr Grfts nd two Dissection NA Stents Two Dissection Endovsculr Grfts nd three Dissection NA 1.7% (1/58) Stents Three Dissection Endovsculr Grfts nd one Dissection Stent NA 3.4% (2/58) Tble 18 provides informtion pertining to the loction of dissection (proximl extent, primry ter, distl extent) s well s the loction in which the Dissection Endovsculr Grft nd Dissection Stent were plced s ssessed by the core lbortory ccording to the zone clssifiction by Fillinger, et l. 1 Zones 2 through 4 were the most common loctions for Dissection Endovsculr Grft plcement, while Zones 4 through 9 were the most common loctions for Dissection Stent

26 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 26 plcement. Although the core lbortory noted grft plcement extending into Zone 1 in 49.3%, none of the ptients hd coverge of the LCC, indicting only portion of the grft (such s long the inner curvture) extended into Zone 1. Tble 18. Dissection Stent nd Dissection Endovsculr Grft coverge reltive to extent of dissection nd primry ter loction ccording to zone clssifiction bsed on core lbortory ssessment Dissection Loction Device Loction (pre-procedure) b (t first follow-up) b Zone Proximl Extent 4.2% (3/72) 6.9% (5/72) 38.9% (28/72) 37.5% (27/72) 5.6% (4/72) 5.6% (4/72) Primry Ter Distl Extent Dissection Endovsculr Grft Dissection Stent % (2/72) 4.2% (3/72) 70.8% (51/72) 15.3% (11/72) % (1/72) 8.3% (6/72) 2.8% (2/72) 2.8% (2/72) 9.7% (7/72) 23.6% (17/72) 19.4% (14/72) 49.3% (34/69) 82.6% (57/69) 88.4% (61/69) 94.2% (65/69) 68.1% (47/69) 5.8% (4/69) % (34/55) 94.5% (52/55) 65.5% (36/55) 65.5% (36/55) 60. (33/55) 54.5% (30/55) 1.8% (1/55) % (14/72) - 1.8% (1/55) Dt re reported s zones 0-11 ccording to the digrm in Fillinger, et l. 1 b Dshes indicte vlue of Tbles 19 nd 20 report dditionl procedures performed (including ccessory device usge) during the time of the index procedure mong ptients with Dissection Stent nd ptients without Dissection Stent, respectively. The mjority of ptients with procedures before device plcement underwent crotid-subclvin bypss. Trnsposition of the LSA, ilic rtery ngioplsty/stent plcement, nd other

27 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 27 procedure types were lso reported. Procedures fter device deployment included trnsposition of the LSA, celic rtery stent plcement, ilic rtery ngioplsty/stent plcement, SMA fenestrtion, nd other procedure types, which often involved renl rtery nd/or SMA stent plcement. Rtes of dditionl procedures were generlly comprble between the two ptient popultions. However, dditionl procedures involving the celic rtery, SMA, nd/or renl rteries (i.e., fenestrtion, ngioplsty, stent plcement) ppered to be more common in ptients who received Dissection Stent, which is consistent with these ptients more often presenting initilly for tretment of mlperfusion s compred to ptients who did not receive Dissection Stent, who often presented for tretment of rupture. Tble 19. Additionl procedures performed nd ccessory device usge during the index procedure in ptients with Dissection Stent Procedure Percent Ptients (number/totl number) Before Device Deployment After Device Deployment Crotid-subclvin bypss 15.5% (9/58) (0/58) LSA trnsposition 5.2% (3/58) 1.7% (1/58) Celic rtery stent (0/58) 1.7% (1/58) Ilic rtery ngioplsty 1.7% (1/58) 1.7% (1/58) Ilic rtery stent or stent-grft 1.7% (1/58) 8.6% (5/58) Renl rtery fenestrtion 1.7% (1/58) 1.7% (1/58) SMA fenestrtion 1.7% (1/58) 3.4% (2/58) Vessel closure device 1.7% (1/58) 1.7% (1/58) Other 8.6% (5/58) 22.4% (13/58) b LCC: left common crotid rtery; LSA: left subclvin rtery; SMA: superior mesenteric rtery. Crotid-to-xillry bypss (n=1); trnsesophgel echo (n=1); explortory lprotomy (n=1); Ampltzer plug plcement to embolize the LSA (n=2). b SMA stent plcement (n=1); esophgogstroduodenoscopy nd esophgectomy (n=1); renl rtery stent plcement (n=2); renl rtery stent plcement, common ilic rtery thrombectomy, nd femorl ptch ngioplsty (n=1); renl rtery stent plcement, SMA stent plcement, nd iliofemorl bypss (n=1); dilysis ctheter insertion (n=1); common ilic rtery endrterectomy nd ptching (n=1); chest tube plcement (n=1); trnsesophgel echo (n=2); fsciotomy (n=1); renl rtery stent plcement nd femorl rtery endrterectomy (n=1). Tble 20. Additionl procedures performed nd ccessory device usge during the index procedure in ptients without Dissection Stent Procedure Percent Ptients (number/totl number) Before Device Deployment After Device Deployment Crotid-subclvin bypss 6.7% (1/15) (0/15) SMA fenestrtion (0/15) 6.7% (1/15) Vessel closure device (0/15) 13.3% (2/15) Other (0/15) 13.3% (2/15) LCC: left common crotid rtery; LSA: left subclvin rtery; SMA: superior mesenteric rtery. Femorl-femorl bypss (n=1); bllooning of true lumen of ort in bdominl region (n=1).

28 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 28 The clinicl utility results re presented in Tble 21. The mesures ppered to be comprble or generlly higher in ptients who received Dissection Stent. Tble 21. Clinicl utility mesures Men ± SD (N, rnge) Vrible Without Dissection Stent With Dissection Stent Totl Dys in ICU 3.2 ± 2.3 (14, 1-10) 7.0 ± 7.3 (57, 0-30) 6.3 ± 6.7 (71, 0-30) Dys to dischrge 12.5 ± 11.0 (15, 2-32) 11.6 ± 9.8 (58, 1-47) 11.8 ± 10.0 (73, 1-47) Dys to first bowel movement 4.1 ± 3.2 (15, 0-12) 4.7 ± 2.9 (48, 0-12) 4.6 ± 2.9 (63, 0-12) Dys to resumption of orl fluid intke 1.1 ± 1.0 (15, 0-3) 3.3 ± 6.1 (50, 0-35) 2.8 ± 5.5 (65, 0-35) Dys to resumption of regulr diet 3.7 ± 4.1 (15, 0-16) 5.5 ± 7.3 (47, 0-35) 5.0 ± 6.7 (62, 0-35) Mechnicl ventiltion (dys) 0.5 ± 0.6 (15, 0-2) 2.0 ± 4.8 (58, 0-28) 1.7 ± 4.3 (73, 0-28) Procedurl intubtion (hours) 7.7 ± 8.5 (15, ) 25.8 ± 64.3 (56, 0-375) 22.0 ± 57.6 (71, 0-375) D. Sfety nd Effectiveness Results As explined bove, the core lb-identified ptients with dissection of the ort proximl to the left subclvin rtery, length < 20 mm between the LCC nd proximl extent of dissection, or with fixtion site dimeters >38 mm were not excluded from the hypotheses-driven nd secondry endpoints nlyses, becuse enrollment in the study ws determined by site evlution. In ddition, inclusion of these ptients would not fvorbly bis the study results. The primry nlysis of sfety nd effectiveness ws bsed on the 67 evluble ptients t the 30-dy time point, excluding the 6 ptients without confirmed bsence of bowel necrosis t the time of enrollment. Tble 22 presents the results of hypothesis testing for the primry endpoint for the Zenith Dissection Endovsculr System. The 30-dy survivl rte ws 95.5%, which met the performnce gol of 79.4% (p < 0.001). Tble 22. Results from primry effectiveness hypothesis testing (30-dy survivl) Performnce 95% Confidence Performnce 30-dy Survivl Rte P-vlue Gol Intervl Gol Met 79.4% 95.5% (64/67) 87%, 99% < Yes 95% confidence intervl ws computed using the Exct method.

29 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 29 There were three ptients who died within 30 dys, the detils of which re provided in Tble 23. Ech deth within 30 dys occurred in ptient who received Dissection Stent. Tble 23. Ptient deths within 30 dys Dys Ptient Number Postprocedure Cuse of Deth CEC Adjudiction * 21 Aortic rupture Unble to be djudicted * 1 Aortic dissection with resultnt Not relted: relted to respirtory filure, crdic rrest presenting ortic dissection Brin ded due to stroke Procedure-relted *Ptient hd length < 20 mm from LCC to proximl extent of dissection, dissection tht extended proximl to the LSA, nd totl ortic dimeter >38 mm t level of LCC/LSA t pre-procedure bsed on core lbortory nlysis. Two of the six ptients excluded from ssessment of the primry effectiveness hypothesis lso died within 30 dys. 1. Additionl Sfety Results Protocol Defined MAEs The dditionl hypothesis-driven nlysis of sfety (30-dy freedom from MAEs) ws bsed on the results from 67 ptients. Dt from 73 ptients re presented for ll other sfety endpoints. The 30-dy freedom from MAE rte ws 71.6%, which met the performnce gol of 51.2% (p < 0.001). The key sfety outcomes for this study re presented below in Tbles 24 nd 25. Adverse effects re reported in Tble 27. Tble 24. Results from primry sfety hypothesis testing (30-dy freedom from MAEs) Performnce 30-dy Freedom from 95% Confidence Performnce P-vlue Gol MAE Rte Intervl Gol Met 51.2% 71.6% (48/67) 59%, 82% < Yes 95% confidence intervl ws computed using the Exct method. There were 19 ptients who experienced MAEs within 30 dys (17 ptients who received Dissection Stent nd 2 ptients without Dissection Stent), s

30 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 30 summrized below in Tble 25. None of the six ptients excluded from ssessment of the primry sfety hypothesis hd MAE within 30 dys. Tble 25. Ptients experiencing MAEs within 30 dys Mjor Adverse Event Ptients without Dissection Stent Ptients with Dissection Stent Totl SVS Acute Ptients Bowel ischemi 3.5% (3/85) MI 1.9% (1/52) 1.5% (1/67) 1.2% (1/85) Prpresis/Prplegi 6.7% (1/15) 5.8% (3/52) 6. (4/67) 9.4% (8/85) Prolonged (> 72 hours) ventiltory support 19.2% (10/52) b 14.9% (10/67) 2.4% (2/85) Renl filure requiring dilysis 6.7% (1/15) 7.7% (4/52) c 7.5% (5/67) 9.4% (8/85) Stroke 9.6% (5/52) d 7.5% (5/67) 9.4% (8/85) MI: myocrdil infrction. Ptient hd length < 20 mm from LCC to proximl extent of dissection nd dissection tht extended proximl to the LSA t pre-procedure bsed on core lbortory nlysis. b Five ptients hd length < 20 mm from LCC to proximl extent of dissection, dissection tht extended proximl to the LSA nd/or totl ortic dimeter > 38 mm t the level of the LCC/LSA t pre-procedure bsed on core lbortory nlysis. c Four ptients hd length < 20 mm from LCC to proximl extent of dissection, dissection tht extended proximl to the LSA, nd/or totl ortic dimeter > 38 mm t the level of the LCC/LSA t pre-procedure bsed on core lbortory nlysis. d Two ptients hd length < 20 mm from LCC to proximl extent of dissection nd/or dissection tht extended proximl to the LSA t pre-procedure bsed on core lbortory nlysis. Of the MAEs tht were ssessed, stroke nd prplegi/prpresis re considered the most serious. While the risk of either one occurring following endovsculr repir of Type B ortic dissection is well known, further investigtion into the possible circumstnces ws wrrnted. Five ptients experienced stroke within 30 dys. Ech stroke occurred in ptient who received Dissection Stent nd ws djudicted by the CEC to be procedurerelted; no stroke ws djudicted s relted to the device. The LSA ws covered in three of the five ptients with stroke, two of which hd undergone revsculriztion. Two ptients pper to hve recovered bsed on norml neurologicl exms reported t subsequent follow-up. The other three, ech without recovery, were notble for potentil contributing fctors such s preexisting Type A dissection, presence of

31 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 31 clcifiction nd thrombus in the proximl sel zone t pre-procedure, nd induced hypotension during the procedure. Four ptients experienced prplegi/prpresis within 30 dys, two recovered nd two were unresolved. The two ptients without resolution of symptoms hd both received spinl cord protection (CSF dringe) t the time of procedure. The preprocedure imging for both ptients ws notble for spinl rteries perfused by the true nd flse lumens, nd on follow-up imging, both hd flse lumen thrombosis tht extended beyond the level of spinl cord injury, suggesting the deficits in both my hve resulted from decresed perfusion of the spinl rteries secondry to flse lumen thrombosis. Not Protocol Defined MAEs While not protocol-defined s MAEs, dditionl (vsculr) events of interest tht were reported by the sites within 30 dys included rupture in 1.4% (1/52 with Dissection Stent, 0/15 without Dissection Stent) nd retrogrde dissection in 1.4% (1/52 with Dissection Stent, 0/15 without Dissection Stent). While there were dditionl reports of rupture (n=1) nd retrogrde dissection (n=3) between dys, ech occurred in ptient with preexisting Type A dissection (i.e., none of the retrogrde dissections were progression of Type B dissection to Type A dissection, s lso noted in Tble 27 Morbidity by ctegory nd type in ll ptients), underscoring the importnce of n dequte proximl lnding zone in non-dissected ort. All-Cuse Mortlity With regrds to the entire study popultion (n=73), deths between 0-30 dys, dys, nd dys occurred in 6.8% (1 relted, 3 unrelted, 1 unble to be djudicted), 7.5% (1 relted, 3 unrelted, 1 unble to be djudicted by the CEC) nd 6.7% (2 unrelted, 2 unble to be djudicted by the CEC), respectively, nd included ptients from both groups (11 with Dissection Stent, 3 without Dissection Stent). Deth rtes between 0-30 dys nd dys were reported in the SVS dtset t 10.6% nd 15.8%, respectively. Tble 26 provides the detils for ll ptient who died within 365 dys.

32 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 32 Tble 26. Ptient deths within 365 dys Dys Ptient Number Postprocedure Cuse of Deth CEC Adjudiction Not relted: relted to deployment Type A ortic dissection with preexisting Type A rupture dissection prior to device Aortic rupture Unble to be djudicted Ischemic bowel Not relted: relted to preexisting condition Multiple orgn filure Not relted: relted to celic rtery nd SMA occlusions prior to Dissection Stent plcement Aortic dissection with resultnt Not relted: relted to respirtory filure, crdic rrest presenting ortic dissection Multiple orgn filure Not relted: ptient did not meet inclusion criteri Angiosrcom, cncer Not relted: relted to other condition Brin ded due to stroke Procedure-relted Unknown Procedure-relted: postopertively the ptient ws ventilted nd hd stroke; however, the terminl event is not cler Unknown, found ded t home Unble to be djudicted Atherosclerotic crdiovsculr disese Unble to be djudicted Unknown Unble to be djudicted Respirtory filure Not relted: relted to pneumoni with preexisting Ischemic hert disese lung cncer nd COPD Not relted: relted to preexisting condition Note: Ptient numbers tht re itlicized indicte those who did not hve confirmed bsence of bowel necrosis t the time of enrollment nd were therefore excluded from hypothesis testing. Ptient hd length < 20 mm from LCC to proximl extent of dissection, dissection tht extended proximl to the LSA, nd/or totl ortic dimeter > 38 mm t the level of the LCC/LSA t preprocedure bsed on core lbortory nlysis. Adverse Effects tht Occurred in the PMA Clinicl Study Tble 27 reports the frequency of ll dverse events ccording to orgn system ctegory nd event type in the overll ptient popultion through 12 months. The occurrence of dverse events ws not unexpected given the extent of comorbid medicl conditions nd disese mong the totl ptient popultion s well s the prevlence of erly nd lte events in similr ctegories for ptients undergoing endovsculr tretment for cute, complicted Type B ortic dissection, s reported in the SVS dtset.

33 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 33 Tble 27. Morbidity by ctegory nd type in ll ptients Ctegory Type Percent Ptients (number/totl number) 0-30 Dys Dys Dys Access site/vessel 9.6% (7/73) 3. (2/67) (0/60) Dehiscence (0/73) (0/67) (0/60) Hemtom 5.5% (4/73) (0/67) (0/60) Herni (0/73) (0/67) (0/60) Infection (0/73) 1.5% (1/67) (0/60) Pseudoneurysm 2.7% (2/73) (0/67) (0/60) Serom 2.7% (2/73) 1.5% (1/67) (0/60) Crdiovsculr 13.7% (10/73) 4.5% (3/67) 1.7% (1/60) Crdic rrhythmi 6.8% (5/73) 1.5% (1/67) 1.7% (1/60) Crdic ischemi 1.4% (1/73) 1.5% (1/67) (0/60) Congestive hert filure (0/73) 1.5% (1/67) (0/60) Myocrdil infrction 1.4% (1/73) (0/67) (0/60) Refrctory hypertension 4.1% (3/73) (0/67) (0/60) Neurologic 11. (8/73) (0/67) 1.7% (1/60) Prplegi 2.7% (2/73) (0/67) (0/60) Prpresis 4.1% (3/73) (0/67) (0/60) Trnsient ischemic ttck (0/73) (0/67) (0/60) Stroke 6.8% (5/73) (0/67) 1.7% (1/60) Gstrointestinl 12.3% (9/73) (0/67) 3.3% (2/60) Bleeding 1.4% (1/73) (0/67) (0/60) Bowel ischemi 1.4% (1/73) (0/67) 3.3% (2/60) Infection 4.1% (3/73) (0/67) (0/60) Bowel obstruction (0/73) (0/67) (0/60) Prlytic ileus > 4 dys 5.5% (4/73) (0/67) (0/60) Pulmonry 21.9% (16/73) 3. (2/67) 1.7% (1/60) COPD (0/73) 3. (2/67) 1.7% (1/60) Hemothorx 1.4% (1/73) (0/67) (0/60) Pleurl effusion 16.4% (12/73) (0/67) (0/60) Pneumoni 2.7% (2/73) (0/67) (0/60) Pneumothorx (0/73) (0/67) (0/60) Pulmonry edem 1.4% (1/73) (0/67) (0/60) Pulmonry embolism 1.4% (1/73) (0/67) (0/60) Renl 17.8% (13/73) 6. (4/67) 5. (3/60) Renl filure 8.2% (6/73) 1.5% (1/67) 1.7% (1/60) Urinry trct infection b 8.2% (6/73) 4.5% (3/67) 3.3% (2/60) Serum cretinine rise c 2.7% (2/73) (0/67) 1.7% (1/60) Vsculr 8.2% (6/73) 4.5% (3/67) 3.3% (2/60) Aortic neurysm 1.4% (1/73) 1.5% (1/67) 1.7% (1/60) Aortic rupture 1.4% (1/73) 1.5% (1/67) (0/60) Aortobronchil fistul (0/73) (0/67) (0/60) Aortoesophgel fistul (0/73) (0/67) (0/60) Aortoenteric fistul (0/73) (0/67) (0/60) Arteril thrombosis (0/73) (0/67) (0/60) Cogulopthy (0/73) (0/67) (0/60) Deep vein thrombosis 2.7% (2/73) (0/67) (0/60) Distl emboliztion d (0/73) (0/67) (0/60) Hemtom (0/73) (0/67) (0/60)

34 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 34 Ctegory Type Percent Ptients (number/totl number) 0-30 Dys Dys Dys Pseudoneurysm e 1.4% (1/73) (0/67) (0/60) Retrogrde dissection f 1.4% (1/73) 3. (2/67) 1.7% (1/60) Miscellneous/other g 68.5% (50/73) 31.3% (21/67) 33.3% (20/60) With or without dilysis. b Requiring ntibiotic tretment. c > 3 bove bseline resulting in persistent vlue > 2.0 mg/dl. d With tissue loss. e Requiring intervention. f Includes retrogrde progression of pre-existing Type A dissection in 3 nd new Type A dissection in 1; none were considered retrogrde progression of Type B dissection to Type A dissection. g Miscellneous morbidity ctegory comprises the following prespecified events: hypersensitivity/llergic rection, multi-orgn filure, sepsis, nd other. 2. Additionl Effectiveness Results Additionl effectiveness outcomes re presented in Tbles 28 to 62, s follows. Aortic Dimeters (Totl Aortic, True Lumen, Flse Lumen) t Follow-up The mximum ortic dimeters just distl to the celic rtery, just distl to the SMA, just distl to the right renl rtery, just distl to the left renl rtery, within the Dissection Endovsculr Grft, nd distl to the treted segment (i.e., most distl stent-grft or Dissection Stent, nd within dissected ort) were mesured by the core lbortory t ech time point for ll ptients. Compred to pre-procedure, the true lumen dimeters trended lrger throughout the viscerl ortic segment t postprocedure. From post-procedure through 12 months, there ppered n increse (> 5 mm) in men true lumen dimeter nd decrese (> 5 mm) in men flse lumen dimeter within the stent-grft. Distl to the treted segment, there ppered to be n increse (> 5 mm) in the men totl ortic dimeter, with no chnge ( 5 mm) in the true nd flse lumen dimeters. Figure 2 plots the verge true nd flse lumen dimeters t the loction of the mximum totl ortic dimeter within nd distl to treted segment.

35 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 35 Figure 2. True nd flse lumen dimeters over time t the loction of the mximum totl ortic dimeter within the stent-grft () nd distl to the treted segment (b) in the totl ptient popultion. Numbers bove the x-xis represent smple number. Dimeters mesured t the specified loctions by the core lbortory t ech time point for the ptients without Dissection Stent nd ptients with Dissection Stent, respectively. Compred to pre-procedure, the true lumen dimeter trended smller t the level of the SMA nd both renl rteries t post-procedure in the ptients without Dissection Stent, wheres the true lumen dimeter trended lrger throughout the

36 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 36 viscerl ortic segment t post-procedure in the ptients with Dissection Stent. In the stent-grft region, there ws n increse (> 5 mm) in verge true lumen dimeter, with no chnge ( 5 mm) in the verge flse lumen or trnsortic dimeters for the ptients without Dissections Stent, compred to n increse (> 5 mm) in verge true lumen dimeter nd decrese (> 5 mm) in the verge flse lumen dimeter, with no chnge ( 5 mm) in totl ortic dimeter for ptients with Dissection Stent. In the Dissection Stent region, there ws no chnge ( 5 mm) in the verge totl ortic, true lumen, or flse lumen dimeters from post-procedure to 12 months. Distl to the treted segment, there ppered n increse (> 5 mm) in the totl nd flse lumen dimeters with no chnge ( 5 mm) in true lumen dimeter for ptients without Dissection Stent, compred to no chnge ( 5 mm) in the totl, true, nd flse lumen dimeters from post-procedure through 12 months for ptients with Dissection Stent. Given these dt, it ppers tht the Dissection Grft results in fvorble remodeling within the region djcent to the Dissection Endovsculr Grft, with the Dissection Stent dditionlly providing for further stbiliztion of ortic dimeters distl to the stent-grft.

37 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 37 Figure 3 illustrtes the verge true nd flse lumen dimeters t the mximum trnsortic dimeter within the Dissection Endovsculr Grft, Dissection Stent (if pplicble), nd distl to the treted segment over time for the ptients with Dissection Stent nd the ptients without Dissection Stent.

38 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 38 Figure 3. True nd flse lumen dimeters over time t the loction of the mximum totl ortic dimeter within nd distl to the specified treted segments for ptients who did not receive Dissection Stent (lbeled s Ptients without Dissection Stent) nd for ptient who received Dissection Stent (lbeled s Ptients with Dissection Stent). Numbers bove the x-xis represent smple number.

39 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 39 Chnge in Trnsortic Dimeter Tbles 28, 29, nd 30 report the percentge of ptients with greter thn 5 mm increse, greter thn 5 mm decrese, or no chnge ( 5 mm) in lrgest size in the trnsortic dimeter within the stent-grft region (depicted in Figure 4) for ptients who did not receive Dissection Stent, ptients who received Dissection Stent, nd the totl ptient popultion, respectively, t ech time point nlyzed. Trnsortic dimeter growth (> 5 mm) in the stent-grft region ws observed in 14.9% t 12 months (6/37 with Dissection Stent, 1/10 without Dissection Stent), including two with net increse (> 5 mm) in flse lumen dimeter (both in the setting of Proximl Type I entry flow), wheres the remining five ptients hd either no chnge ( 5 mm) or net decrese (> 5 mm) in flse lumen dimeter. Figure 4. Digrm of the Zenith Dissection Endovsculr System depicting stent-grft region (between the red rrows)

40 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 40 Tble 28. Chnge in trnsortic dimeter within the stent-grft for ptients who did not receive Dissection Stent bsed on results from core lbortory nlysis Percent Ptients (number/totl number) Sttus 6-month 12-month Increse 25. (3/12),b,c 10. (1/10) Decrese 16.7% (2/12) 20. (2/10) No chnge 58.3% (7/12) 70. (7/10) Note: Footnotes provide the chnges in true nd flse lumen dimeters s of 12-month follow-up. Ptient : True lumen: -2.7 mm, Flse Lumen: mm. Ptient hs Type I proximl entry-flow, secondry ter in the descending thorcic ort, nd collterl flow from intercostl nd prspinl rteries. Ptient hd length < 20 mm from LCC to proximl extent of dissection nd dissection tht extended proximl to the LSA t pre-procedure bsed on core lbortory nlysis. b Ptient : True lumen: +7.8 mm, Flse Lumen: -2.0 mm. c Ptient : True lumen: mm, Flse Lumen: -8.4 mm. Tble 29. Chnge in trnsortic dimeter within the stent-grft for ptients who received Dissection Stent bsed on results from core lbortory nlysis Percent Ptients (number/totl number) Sttus 6-month 12-month Increse 16.3% (7/43),b,c,d,e,f,g 16.2% (6/37) b,c,d,f,g,h Decrese 20.9% (9/43) 27. (10/37) No chnge 62.8% (27/43) 56.8% (21/37) Ptient : True lumen: -0.6 mm, Flse Lumen: +8.3 mm. The true lumen hs expnded nd the flse lumen hs decresed. The thorcic flse lumen is completely thrombosed. b Ptient : True lumen: mm, Flse Lumen: -3.7 mm. c Ptient : True lumen: +5.7 mm, Flse Lumen: -0.5 mm. d Ptient : True lumen: -1.2 mm, Flse Lumen: +7.6 mm. Ptient hs Type I proximl entry-flow. Ptient hd length < 20 mm from LCC to proximl extent of dissection nd dissection tht extended proximl to the LSA t pre-procedure bsed on core lbortory nlysis. e Ptient : True lumen: -2.6 mm, Flse Lumen: +6.9 mm. Ptient hs collterl flow from the prspinl rteries. f Ptient : True lumen: mm, Flse Lumen: -7.0 mm. g Ptient : True lumen: mm, Flse Lumen: mm. h Ptient : True lumen: +1.2 mm, Flse Lumen: +4.5 mm. Ptient hs collterl flow from the spinl rteries. Tble 30. Chnge in trnsortic dimeter within the stent-grft for ll ptients bsed on results from core lbortory nlysis Sttus Percent Ptients (number/totl number) 6-month 12-month Increse Decrese No chnge 18.2% (10/55) 20. (11/55) 61.8% (34/55) 14.9% (7/47) 25.5% (12/47) 59.6% (28/47)

41 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 41 Tble 31 reports the percentge of ptients with greter thn 5 mm increse, greter thn 5 mm decrese, or no chnge ( 5 mm) in lrgest size in the trnsortic dimeter within the Dissection Stent region (depicted in Figure 5). Trnsortic dimeter growth (> 5 mm) in the Dissection Stent region ws observed in 38.5% t 12 months, including six with net increse (> 5 mm) in flse lumen dimeter (ech in the setting of flse lumen perfusion from secondry ters nd ptent collterl vessels), wheres the remining nine ptients hd no chnge ( 5 mm) in flse lumen dimeter. Figure 5. Digrm of Zenith Dissection Endovsculr System depicting Dissection Stent region (between the green rrows) Tble 31. Chnge in trnsortic dimeter within the Dissection Stent region bsed on results from core lbortory nlysis Percent Ptients (number/totl number) Sttus 6-month 12-month Increse 20.5% (9/44) -i 38.5% (15/39) d-r Decrese 4.5% (2/44) 5.1% (2/39) No chnge 75. (33/44) 56.4% (22/39) Note: Footnotes provide the chnges in true nd flse lumen dimeters s of 12-month follow-up. Ptient : True lumen: +3.6 mm, Flse Lumen: -3.8 mm. b Ptient : True lumen: +2.6 mm, Flse Lumen: +0.9 mm. At 6 months, growth ws potentilly due to secondry ter in the descending thorcic ort. At 12 months, the true lumen hd expnded nd the thorcic flse lumen ws completely thrombosed. c Ptient : True lumen: -0.6 mm, Flse Lumen: mm. Ptient hs secondry ter t the right renl rtery nd collterl flow from the lumbr rteries. d Ptient : True lumen: +2.4 mm, Flse Lumen: +5.0 mm. Ptient hs completely thrombosed thorcic flse lumen, but secondry ter t the right renl rtery nd collterl flow from the prspinl nd lumbr rteries.

42 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 42 e Ptient : True lumen: +4.0 mm, Flse Lumen: +4.5 mm. Ptient hs completely thrombosed thorcic flse lumen, but secondry ter t the infrrenl ort nd collterl flow from the lumbr rteries. f Ptient : True lumen: -1.9 mm, Flse Lumen: 14.3 mm. Ptient hs secondry ters in the descending thorcic nd infrrenl ort nd collterl flow from the prspinl nd lumbr rteries. g Ptient : True lumen: +6.0 mm, Flse Lumen: +8.1 mm. Ptient hs secondry ter in the infrrenl ort nd collterl flow from the prspinl nd lumbr rteries. h Ptient : True lumen: +7.4 mm, Flse Lumen: +4.0 mm. Ptient hs secondry ters in the descending thorcic ort nd t the SMA s well s collterl flow from the prspinl nd lumbr rteries. i Ptient : True lumen: +3.8 mm, Flse Lumen: +2.0 mm. Ptient hs completely thrombosed thorcic flse lumen, but hs secondry ter t the right renl rtery nd collterl flow from the lumbr rteries. j Ptient : True lumen: -1.8 mm, Flse Lumen: +9.2 mm. Ptient hs Type I proximl entry-flow nd collterl flow from the lumbr rteries. Ptient hd length < 20 mm from LCC to proximl extent of dissection, dissection tht extended proximl to the LSA, nd n ortic dimeter >38 mm t the level of the LCC/LSA t pre-procedure bsed on core lbortory nlysis. k Ptient : True lumen: +1.0 mm, Flse Lumen: +4.5 mm. Ptient hs completely thrombosed thorcic flse lumen, but hs secondry ter t the infrrenl ort nd celic rtery nd collterl flow from the lumbr rteries. l Ptient : True lumen: -0.9 mm, Flse Lumen: +6.0 mm. Ptient hs secondry ters in the descending thorcic nd infrrenl ort nd collterl flow from the prspinl nd lumbr rteries. m Ptient : True lumen: +7.6 mm, Flse Lumen: +2.2 mm. n Ptient : True lumen: +1.0 mm, Flse Lumen: +4.9 mm. Ptient hs completely thrombosed thorcic flse lumen, but hs secondry ters t the celic rtery nd SMA nd collterl flow from the lumbr rteries. o Ptient : True lumen: +2.8 mm, Flse Lumen: +4.4 mm. Ptient hs prtilly thrombosed bdominl flse lumen, but hs collterl flow from the prspinl rtery. p Ptient : True lumen: -1.6 mm, Flse Lumen: mm. Ptient hs n unknown entryflow, secondry ter t the SMA, nd collterl flow from the prspinl nd lumbr rteries. q Ptient : True lumen: -3.5 mm, Flse Lumen: +8.8 mm. Ptient hs secondry ter t the left renl rtery nd collterl flow from the prspinl nd lumbr rteries. r Ptient : True lumen: +2.2 mm, Flse Lumen: +3.0 mm. Ptient hs completely thrombosed thorcic flse lumen, but hs secondry ters t the right renl nd celic rteries nd collterl flow from the lumbr rteries. Tbles 32, 33, nd 34 report the percentge of ptients with greter thn 5 mm increse, greter thn 5 mm decrese, or no chnge ( 5 mm) in lrgest size in the trnsortic dimeter distl to the treted segment for ptients who did not receive Dissection Stent, ptients who received Dissection Stent, nd the totl ptient popultion, respectively, t ech time point nlyzed. As with the other tbles reporting chnge in size, the denomintors reflect the number of ptients with bseline exm who lso hd dequte imging extending to the level of interest, which in this cse ws beyond the level of the treted segment. Trnsortic dimeter growth (> 5 mm) distl to the treted segment ws observed in 40.7% t 12 months (8 with Dissection Stent, 3 without Dissection Stent), including seven with net increse (> 5 mm) in flse lumen dimeter (ech in the

43 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 43 setting of flse lumen perfusion from secondry ters nd ptent collterl vessels), one with net decrese (> 5 mm) in flse lumen dimeter, nd three with no chnge ( 5 mm) in flse lumen dimeter. Tble 32. Chnge in trnsortic dimeter distl to the treted segment nd within dissected ort for ptients who did not receive Dissection Stent bsed on results from core lbortory nlysis Percent Ptients (number/totl number) Sttus 6-month 12-month Increse Decrese No chnge 16.7% (1/6) 83.3% (5/6) 60. (3/5) -c 40. (2/5) Note: Footnotes provide the chnges in true nd flse lumen dimeters s of 12-month follow-up. Ptient : True lumen: +1.1 mm, Flse Lumen: +5.7 mm. Ptient hs secondry ters t the infrrenl ort nd t the celic rtery nd collterl flow from the intercostl, prspinl, nd lumbr rteries. b Ptient : True lumen: -0.6 mm, Flse Lumen: +6.4 mm. Ptient hs collterl flow from the intercostl rteries. c Ptient : True lumen: -3.0 mm, Flse Lumen: +9.7 mm. Ptient hs Type I proximl entry-flow, secondry ter in the descending thorcic ort, nd collterl flow from the intercostl nd prspinl rteries. Ptient hd length < 20 mm from LCC to proximl extent of dissection nd dissection tht extended proximl to the LSA t pre-procedure bsed on core lbortory nlysis. Tble 33. Chnge in trnsortic dimeter distl to the treted segment nd within dissected ort for ptients who received Dissection Stent bsed on results from core lbortory nlysis Percent Ptients (number/totl number) Sttus 6-month 12-month Increse Decrese No chnge 13. (3/23) -c 87. (20/23) 36.4% (8/22) -h 63.6% (14/22) Note: Footnotes provide the chnges in true nd flse lumen dimeters s of 12-month follow-up. Ptient : True lumen: +7.3 mm, Flse Lumen: +1.9 mm. Ptient hs prtilly thrombosed thorcic flse lumen, but hs secondry ter t the left renl rtery nd collterl flow from the lumbr rteries. b Ptient : True lumen: +9.3 mm, Flse Lumen: mm. Ptient hs completely thrombosed thorcic flse lumen, but hs secondry ter t the right renl rtery nd collterl flow from the lumbr rteries. c Ptient : True lumen: +0.4 mm, Flse Lumen: +5.0 mm. Ptient hs secondry ters in the infrrenl ort nd t the celic rtery nd collterl flow from the lumbr rteries. d Ptient : True lumen: +0.3 mm, Flse Lumen: +5.1 mm. Ptient hs secondry ter t the right renl nd celic rteries nd collterl flow from the lumbr rteries. e Ptient : True lumen: +3.7 mm, Flse Lumen: +1.8 mm. Ptient hs completely thrombosed thorcic flse lumen, but hs secondry ter in the infrrenl ort nd collterl flow from the lumbr rteries. f Ptient : True lumen: +0.9 mm, Flse Lumen: mm. Ptient hs secondry ters in the descending thorcic nd infrrenl ort nd collterl flow from the prspinl nd collterl rteries. g Ptient : True lumen: -2.4 mm, Flse Lumen: mm. Ptient hs completely thrombosed thorcic flse lumen, but hs secondry ters in the infrrenl ort nd t the celic rtery nd collterl flow from the lumbr rteries.

44 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 44 h Ptient : True lumen: mm, Flse Lumen: -7.5 mm. Tble 34. Chnge in trnsortic dimeter distl to the treted segment nd within dissected ort for ll ptients bsed on results from core lbortory nlysis Sttus Percent Ptients (number/totl number) 6-month 12-month Increse Decrese No chnge 13.8% (4/29) 86.2% (25/29) 40.7% (11/27) 59.3% (16/27) Flse Lumen Perfusion Tbles 35, 36, nd 37 detil the sources of flow in the thorcic flse lumen in ptients who did not receive Dissection Stent, ptients who received Dissection Stent, nd the totl ptient popultion, respectively. It should be noted tht per the definitions in the study protocol, Types I through IV re intended to describe the source(s) for flow into the flse lumen vi the primry entry ter, nd therefore speks to the effectiveness of the endovsculr grft component in seling the primry entry ter (nlogous to the endolek types for neurysm repir i.e., Type I = proximl nd/or distl sel; Type II = vessels covered by grft; Type III = grft defect/hole or overlp; Type IV = grft porosity). However, recognizing the primry entry ter is not the only source for flse lumen perfusion, it ws necessry to further describe sources for flse lumen flow not specificlly ssocited with the effectiveness of the stent-grft to sel the primry entry ter. Therefore, the core lbortory lso noted ny incidences of flow directly into the flse lumen vi secondry ters or collterl vessels. The mjority of reports of flse lumen flow during follow-up were through secondry ters or collterl vessels, the coverge/occlusion of which were t physicin discretion. Seven cses of Type I proximl entry flow into the thorcic flse lumen were observed through 12 months. However, ech ptient hd evidence of n indequte proximl lnding zone (i.e., ortic dimeter > 38 mm nd/or length of non-dissected ort < 20 mm) nd often times lso grft undersizing. Overll, the proximl Type I entry-flow rte ws 6.4% t 12 months (2 with Dissection Stent, 1 without Dissection Stent).

45 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 45 Tble 35. Entry-flow in the thorcic ort for ptients who did not receive Dissection Stent bsed on results from core lbortory nlysis Source Percent Ptients (number/totl number) Post-procedure 1-month 6-month 12-month Multiple 16.7% (1/6) 25. (3/12) 10. (1/10) 11.1% (1/9) Type I proximl 8.3% (1/12) 10. (1/10) b 11.1% (1/9) b Type I distl Type II Type III Type IV Type unknown Collterl 66.7% (4/6) 41.7% (5/12) 40. (4/10) 44.4% (4/9) Secondry ter 16.7% (1/6) 33.3% (4/12) 10. (1/10) 11.1% (1/9) Totl ptients 66.7% (4/6) 50. (6/12) 50. (5/10) 44.4% (4/9) Ptient hd Type I proximl entry-flow noted t 1 month in the likely setting of grft undersizing s well s n indequte proximl lnding zone (dimeter nd length) reltive to the loction of grft plcement ccording to mesurements by the core lbortory. The ptient ws treted with ncillry devices to mitigte the entry-flow. The ptient lso presented with preexisting Type A dissection ccording to CEC djudiction. b Ptient hd Type I proximl entry-flow first noted t 54 dys post-procedure (unscheduled visit) in the likely setting of n indequte proximl lnding zone (length) reltive to the loction of grft plcement ccording to mesurements by the core lbortory. This entry-flow hs persisted through 12 months. No secondry interventions hve been performed t this time to tret this entry-flow. Tble 36. Entry-flow in the thorcic ort for ptients who received Dissection Stent bsed on results from core lbortory nlysis Source Percent Ptients (number/totl number) Post-procedure 1-month 6-month 12-month Multiple 33.3% (9/27) 16.2% (6/37) 26.8% (11/41) 15.8% (6/38) Type I proximl 3.7% (1/27) 8.1% (3/37) b-d 4.9% (2/41),c 5.3% (2/38) c,e Type I distl Type II Type III Type IV Type unknown 2.7% 2.4% (1/41) 2.6% (1/38) Collterl 55.6% (15/27) 43.2% (16/37) 41.5% (17/41) 36.8% (14/38) Secondry ter 37. (10/27) 27. (10/37) 34.1% (14/41) 18.4% (7/38) Totl ptients 63. (17/27) 62.2% (23/37) 51.2% (21/41) 47.4% (18/38) Ptient hd Type I proximl entry-flow noted t post-procedure nd t 6 months in the likely setting of n indequte proximl lnding zone (length) reltive to the loction of grft plcement ccording to mesurements by the core lbortory. The ptient died 306 dys postprocedure (CEC unble to djudicte) with no secondry interventions performed to tret this entry-flow. b Ptient hd Type I proximl entry-flow noted t 1 month in the likely setting of grft undersizing s well s n indequte proximl lnding zone (dimeter nd length) reltive to the loction of grft plcement ccording to mesurements by the core lbortory. The entry-flow ws completely resolved t 6 months. c Ptient hd Type I proximl entry-flow tht ws treted with surgicl repir in the likely setting of grft undersizing s well s n indequte proximl lnding zone (dimeter nd length) reltive to the loction of grft plcement ccording to mesurements by the core

46 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 46 lbortory. The ptient underwent surgicl repir involving the scending ort nd rch 153 dys post-procedure. The Type I proximl entry-flow hs persisted through 2yers. d Ptient hd Type I proximl entry-flow noted t 1 month in the likely setting of grft undersizing s well s n indequte proximl lnding zone (length) reltive to the loction of grft plcement ccording to mesurements by the core lbortory. No secondry interventions hve been performed t this time to tret this entry-flow. e Ptient hd Type I proximl entry-flow noted t 12 months in the likely setting of grft undersizing s well s n indequte proximl lnding zone (length) reltive to the loction of grft plcement ccording to mesurements by the core lbortory. The Type I proximl entryflow hs persisted through 2 yers. No secondry interventions hve been performed t this time to tret this entry-flow. Tble 37. Entry-flow in the thorcic ort for ll ptients bsed on results from core lbortory nlysis Source Percent Ptients (number/totl number) Post-procedure 1-month 6-month 12-month Multiple 30.3% (10/33) 18.4% (9/49) 23.5% (12/51) 14.9% (7/47) Type I proximl 3. (1/33) 8.2% (4/49) 5.9% (3/51) 6.4% (3/47) Type I distl Type II Type III Type IV Type unknown 2. (1/49) 2. (1/51) 2.1% (1/47) Collterl 57.6% (19/33) 42.9% (21/49) 41.2% (21/51) 38.3% (18/47) Secondry ter 33.3% (11/33) 28.6% (14/49) 29.4% (15/51) 17. (8/47) Totl ptients 63.6% (21/33) 59.2% (29/49) 51. (26/51) 46.8% (22/47) Tbles 38, 39, nd 40 detil the sources of entry-flow in the bdominl flse lumen in ptients who did not receive Dissection Stent, ptients who received Dissection Stent, nd the totl ptient popultion, respectively. The mjority of ptients hd bdominl flse lumen flow through secondry ters nd/or collterl vessels, the coverge/occlusion of which were t physicin discretion. The single ptient with Type I proximl entry-flow in the bdominl ort is one of the sme ptients who ws noted to hve thorcic flse lumen perfusion through proximl Type I entry-flow in the setting of pprent grft undersizing s well s n indequte proximl lnding zone (dimeter nd length) bsed on core lbortory mesurements reltive to the loction of grft plcement.

47 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 47 Tble 38. Entry-flow in the bdominl ort for ptients who did not receive Dissection Stent bsed on results from core lbortory nlysis Source Percent Ptients (number/totl number) Post-procedure 1-month 6-month 12-month Multiple 33.3% (2/6) 20. (2/10) 22.2% (2/9) 33.3% (2/6) Type I proximl Type I distl Type II Type III Type IV Type unknown Collterl 50. (3/6) 40. (4/10) 44.4% (4/9) 33.3% (2/6) Secondry ter 33.3% (2/6) 20. (2/10) 33.3% (3/9) 50. (3/6) Totl ptients 50. (3/6) 40. (4/10) 55.6% (5/9) 50. (3/6) Tble 39. Entry-flow in the bdominl ort for ptients who received Dissection Stent bsed on results from core lbortory nlysis Source Percent Ptients (number/totl number) Post-procedure 1-month 6-month 12-month Multiple 81.5% (22/27) 70.3% (26/37) 63.2% (24/38) 66.7% (26/39) Type I proximl 2.7% (1/37) Type I distl Type II Type III Type IV Type unknown 2.6% (1/38) (0/39) Collterl 92.6% (25/27) 81.1% (30/37) 84.2% (32/38) 76.9% (30/39) Secondry ter 88.9% (24/27) 75.7% (28/37) 71.1% (27/38) 74.4% (29/39) Totl ptients 100. (27/27) 89.2% (33/37) 92.1% (35/38) 84.6% (33/39) Ptient underwent surgicl repir 153 dys post-procedure in the likely setting of grft undersizing s well s n indequte proximl lnding zone (dimeter nd length) reltive to the loction of grft plcement ccording to mesurements by the core lbortory. The ptient underwent surgicl repir involving the scending ort nd rch 153 dys post-procedure. Tble 40. Entry-flow in the bdominl ort for ll ptients bsed on results from core lbortory nlysis Source Percent Ptients (number/totl number) Post-procedure 1-month 6-month 12-month Multiple 72.7% (24/33) 59.6% (28/47) 55.3% (26/47) 62.2% (28/45) Type I proximl 2.1% (1/47) Type I distl Type II Type III Type IV Type unknown 2.1% (1/47) Collterl 84.8% (28/33) 72.3% (34/47) 76.6% (36/47) 71.1% (32/45) Secondry ter 78.8% (26/33) 63.8% (30/47) 63.8% (30/47) 71.1% (32/45) Totl ptients 90.9% (30/33) 78.7% (37/47) 85.1% (40/47) 80. (36/45)

48 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 48 Flse Lumen Sttus Tbles 41, 42, nd 43 present dt for flse lumen sttus within the stent-grft region for ptients who did not receive Dissection Stent, ptients who received Dissection Stent, nd the totl ptient popultion, respectively. There were no ptients with ptent flse lumen in the region of the stent-grft t 12 months, nd 80.4% hd complete thrombosis (including those no longer with n pprent flse lumen), which ppered greter in the ptients with Dissection Stent (89.2%) compred to the ptients without Dissection Stent (44.4%). Tble 41. Sttus of flse lumen within the stent-grft for ptients who did not receive Dissection Stent bsed on results from core lbortory nlysis Percent Ptients (number/totl number) Sttus Postprocedure 1-month 6-month 12-month Ptent 8.3% (1/12) Prtilly thrombosed Completely thrombosed No pprent flse lumen 66.6% (4/6) 33.3% (2/6) (0/6) 41.7% (5/12) 50. (6/12) (0/12) 50. (5/10) 40. (4/10) 10. (1/10) 55.6% (5/9) 33.3% (3/9) 11.1% (1/9) Ptient : flse lumen flow through secondry ter in the descending thorcic ort s well s collterl vessels reported t this time point; the flse lumen in the stent-grft region ws prtilly thrombosed t 6 nd 12 months. Tble 42. Sttus of flse lumen within the stent-grft for ptients who received Dissection Stent bsed on results from core lbortory nlysis Percent Ptients (number/totl number) Sttus Postprocedure 1-month 6-month 12-month Ptent Prtilly thrombosed Completely thrombosed No pprent flse lumen 46.4% (13/28) 53.6% (15/28) (0/28) 38.9% (14/36) 55.6% (20/36) 5.6% (2/36) 26.8% (11/41) 63.4% (26/41) 9.8% (4/41) 10.8% (4/37) 81.1% (30/37) 8.1% (3/37) Tble 43. Sttus of flse lumen within the stent-grft for ll ptients bsed on results from core lbortory nlysis Percent Ptients (number/totl number) Sttus Postprocedure 1-month 6-month 12-month Ptent 2.1% (1/48) Prtilly thrombosed Completely thrombosed No pprent flse lumen 50. (17/34) 50. (17/34) (0/34) 39.6% (19/48) 54.2% (26/48) 2.1% (2/48) 31.4% (16/51) 58.8% (30/51) 9.8% (5/51) 19.6% (9/46) 71.7% (33/46) 8.7% (4/46) Figure 6 depicts the percentges for flse lumen sttus within the stent-grft region for ech group over time, s reported in Tbles 41, 42, nd 43.

49 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 49 Figure 6. Flse lumen sttus within the stent-grft for ptients who did not receive Dissection Stent (lbeled s ptients without Dissection Stent), ptients who received Dissection Stent (lbeled s ptients with Dissection Stent), nd the totl ptient popultion

50 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 50 Tble 44 presents dt for flse lumen sttus within the Dissection Stent region over time bsed on core lbortory nlysis. The rte of flse lumen ptency decresed over time whereby the mjority of ptients (97.5%) hd either prtil thrombosis, complete thrombosis, or no pprent flse lumen ny longer within the Dissection Stent region t 12 months. The one ptient (2.6%) with ptent flse lumen t 12 months (lso with flse lumen perfusion from secondry ters nd ptent collterls) hd prtilly thrombosed flse lumen in this region t subsequent follow-up. Tble 44. Sttus of flse lumen within the Dissection Stent bsed on results from core lbortory nlysis Sttus Percent Ptients (number/totl number) Post-procedure 1-month 6-month 12-month Ptent Prtilly thrombosed Completely thrombosed No pprent flse lumen 10.7% (3/28),b,c 85.7% (24/28) 3.6% (1/28) 11.1% (4/36) c,d,e,f 83.3% (30/36) 5.6% (2/36) 2.4% (1/41) g 80.5% (33/41) 14.6% (6/41) 2.4% (1/41) i 2.6% (1/39) h 79.5% (31/39) 15.4% (6/39) 2.6% (1/39) i Ptient : the flse lumen in the Dissection Stent region ws not ssessed t 1 month nd ws prtilly thrombosed t 6 nd 12 months. b Ptient : the ptient died 96 dys post-procedure (CEC unble to djudicte), prior to completing ny dditionl follow-up visits. c Ptient : the ptient ws lost-to-follow up following the 1-month imging. d Ptient : the flse lumen in the Dissection Stent region ws prtilly thrombosed t 6 nd 12 months. e Ptient : the flse lumen in the Dissection Stent region ws prtilly thrombosed t postprocedure nd 6 months; the ptient died 330 dys post-procedure (CEC unble to djudicte), prior to completing the 12-month follow-up visit. f Ptient : the flse lumen in the Dissection Stent region ws prtilly thrombosed t 6 nd 12 months. g Ptient : the flse lumen in the Dissection Stent region ws prtilly thrombosed t post procedure, 1 month, nd 12 months. h Ptient : the flse lumen in the Dissection Stent region ws prtilly thrombosed t postprocedure, 1 month, nd 2 yers. The flse lumen in this region ws not ssessed t 6 months. Figure 7 provides visul representtion of the dt for flse lumen sttus within the Dissection Stent region over time, s reported in Tble 44.

51 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 51 Figure 7. Flse lumen sttus within the Dissection Stent Tbles 45, 46, nd 47 present dt for flse lumen sttus distl to the treted segment for ptients who did not receive Dissection Stent, ptients who received Dissection Stent, nd the totl ptient popultion, respectively. Distl to the treted segment, flse lumen ptency ws noted in 17% of ptients t 12 months (7 with Dissection Stent, 1 without Dissection Stent). While the rte of flse lumen ptency distl to the treted segment initilly ppered higher (t post-procedure) in the ptients with Dissection Stent, the rtes were more comprble between groups by 12 months; trend towrds higher percentge of ptients with ptent flse lumen distl to the treted segment is not unexpected for the group with Dissection Stent s these ptients tended to more often present with secondry ters, prticulrly in loctions distl to the stent-grft (i.e., in the region of the brnch vessels nd bdominl ort) s compred to ptients who did not receive Dissection Stent.

52 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 52 Tble 45. Sttus of flse lumen distl to the treted segment for ptients who did not receive Dissection Stent bsed on results from core lbortory nlysis Percent Ptients (number/totl number) Sttus Postprocedure 1-month 6-month 12-month Ptent 16.7% (1/6) 16.7% (2/12) b,c 10. (1/10) 11.1% (1/9) Prtilly thrombosed Completely thrombosed No pprent flse 33.3% (2/6) 33.3% (2/6) 16.7% (1/6) 25. (3/12) 33.3% (4/12) 25. (3/12) 40. (4/10) 10. (1/10) 40. (4/10) 22.2% (2/9) 22.2% (2/9) 44.4% (4/9) lumen Ptient b Ptient c Ptient : prtilly thrombosed t subsequent time points Tble 46. Sttus of flse lumen distl to the treted segment for ptients who received Dissection Stent bsed on results from core lbortory nlysis Percent Ptients (number/totl number) Sttus Post-procedure 1-month 6-month 12-month Ptent 57.1% (16/28) -p 22.7% (9/35) i-l,o-s 25.6% (10/39) e,f,i,l,o,p,r,t,u,v 18.4% (7/38) b,i,p,r,s,t,w Prtilly thrombosed 21.4% (6/28) 37.1% (13/35) 48.7% (19/39) 50. (19/38) Completely thrombosed 3.6% (1/28) (0/35) 5.1% (2/39) 5.3% (2/38) No pprent flse 19.7% (5/28) 37.1% (13/35) 20.5% (8/39) 26.3% (10/38) lumen Ptient : prtilly thrombosed t subsequent time points. b Ptient c Ptient : prtilly thrombosed t subsequent time points. d Ptient e Ptient : n/ t 1-month, prtilly thrombosed t subsequent time points. f Ptient g Ptient h Ptient : prtilly thrombosed t subsequent time points. i Ptient j Ptient : prtilly thrombosed t subsequent time points. k Ptient l Ptient m Ptient n Ptient : n/ t 1-month, prtilly thrombosed t subsequent time points. o Ptient : prtilly thrombosed t subsequent time points. p Ptient : prtilly thrombosed t subsequent time points. q Ptient : n/ t 6-month, prtilly thrombosed t 12-month. r Ptient s Ptient t Ptient u Ptient v Ptient : prtilly thrombosed t subsequent time points. w Ptient Tble 47. Sttus of flse lumen distl to the treted segment for ll ptients bsed on results from core lbortory nlysis Sttus Percent Ptients (number/totl number) Post-procedure 1-month 6-month 12-month Ptent Prtilly thrombosed Completely thrombosed No pprent flse lumen 50. (17/34) 23.3% (8/34) 8.8% (3/34) 17.6% (6/34) 23.4% (11/47) 34. (16/47) 8.5% (4/47) 34. (16/47) 22.4% (11/49) 46.9% (23/49) 6.1% (3/49) 24.5% (12/49) 17. (8/47) 44.7% (21/47) 8.5% (4/47) 29.8% (14/47)

53 Summry of Clinicl Dt for IFU EN (Zenith Dissection Endovsculr System) 53 Figure 8 provides visul representtion of the dt for flse lumen sttus distl to the treted segment for ech group over time, s reported in Tbles 45, 46, nd 47. Figure 8. Flse lumen sttus distl to the treted segment for ptients who did not receive Dissection Stent (lbeled s ptients without Dissection Stent), ptients who received Dissection Stent (lbeled s ptients with Dissection Stent), nd the totl ptient popultion

Supplementary Online Content

Supplementary Online Content Supplementry Online Content Zulmn DM, Pl Chee C, Ezeji-Okoye SC, et l. Effect of n intensive outptient progrm to ugment primry cre for high-need Veterns Affirs ptients: rndomized clinicl tril. JAMA Intern

More information

Clinical Study Report Synopsis Drug Substance Naloxegol Study Code D3820C00018 Edition Number 1 Date 01 February 2013 EudraCT Number

Clinical Study Report Synopsis Drug Substance Naloxegol Study Code D3820C00018 Edition Number 1 Date 01 February 2013 EudraCT Number EudrCT Number 2012-001531-31 A Phse I, Rndomised, Open-lbel, 3-wy Cross-over Study in Helthy Volunteers to Demonstrte the Bioequivlence of the Nloxegol 25 mg Commercil nd Phse III Formultions nd to Assess

More information

Impact of Pharmacist Intervention on Diabetes Patients in an Ambulatory Setting

Impact of Pharmacist Intervention on Diabetes Patients in an Ambulatory Setting Impct of Phrmcist Intervention on Dibetes Ptients in n Ambultory Setting Julie Stding, PhrmD, CDE, Jmie Herrmnn, PhrmD, Ryn Wlters, MS, Chris Destche, PhrmD, nd Aln Chock, PhrmD Dibetes is the seventh-leding

More information

Community. Profile Big Horn County. Public Health and Safety Division

Community. Profile Big Horn County. Public Health and Safety Division Community Helth Profile 2015 Big Horn County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl

More information

SYNOPSIS Final Abbreviated Clinical Study Report for Study CA ABBREVIATED REPORT

SYNOPSIS Final Abbreviated Clinical Study Report for Study CA ABBREVIATED REPORT Finl Arevited Clinicl Study Report Nme of Sponsor/Compny: Bristol-Myers Squi Ipilimum Individul Study Tle Referring to the Dossier (For Ntionl Authority Use Only) Nme of Finished Product: Yervoy Nme of

More information

Community. Profile Powell County. Public Health and Safety Division

Community. Profile Powell County. Public Health and Safety Division Community Helth Profile 2015 Powell County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl Risk

More information

Community. Profile Yellowstone County. Public Health and Safety Division

Community. Profile Yellowstone County. Public Health and Safety Division Community Helth Profile 2015 Yellowstone County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl

More information

Community. Profile Missoula County. Public Health and Safety Division

Community. Profile Missoula County. Public Health and Safety Division Community Helth Profile 2015 Missoul County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl Risk

More information

Community. Profile Lewis & Clark County. Public Health and Safety Division

Community. Profile Lewis & Clark County. Public Health and Safety Division Community Helth Profile 2015 Lewis & Clrk County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl

More information

Community. Profile Anaconda- Deer Lodge County. Public Health and Safety Division

Community. Profile Anaconda- Deer Lodge County. Public Health and Safety Division Community Helth Profile 2015 Ancond- Deer Lodge County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12

More information

Emerging Options for Thromboprophylaxis After Orthopedic Surgery: A Review of Clinical Data

Emerging Options for Thromboprophylaxis After Orthopedic Surgery: A Review of Clinical Data Emerging Options for Thromboprophylxis After Orthopedic Surgery: A Review of Clinicl Dt Bob L. Lobo, Phrm.D. In four rndomized, controlled studies of ptients undergoing orthopedic surgery, the ntithrombotic

More information

Community. Profile Carter County. Public Health and Safety Division

Community. Profile Carter County. Public Health and Safety Division Community Helth Profile 2015 Crter County Public Helth nd Sfety Division Tble of Contents Demogrphic Informtion 1 Communicble Disese 3 Chronic Disese 4 Mternl nd Child Helth 10 Mortlity 12 Behviorl Risk

More information

CheckMate 153: Randomized Results of Continuous vs 1-Year Fixed-Duration Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer

CheckMate 153: Randomized Results of Continuous vs 1-Year Fixed-Duration Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer CheckMte 53: Rndomized Results of Continuous vs -Yer Fixed-Durtion Nivolumb in Ptients With Advnced Non-Smll Cell Lung Cncer Abstrct 297O Spigel DR, McCleod M, Hussein MA, Wterhouse DM, Einhorn L, Horn

More information

The Association of Gender With Quality of Health in Peripheral Arterial Disease Following Peripheral Vascular Intervention

The Association of Gender With Quality of Health in Peripheral Arterial Disease Following Peripheral Vascular Intervention The Assocition of Gender With Qulity of Helth in Peripherl Arteril Disese Following Peripherl Vsculr Intervention Sudrshn Pudel, MD 1 ; Anwr Zitoun, MD 1 ; Sif Al-Njfi, MD 2 ; Ther Mus, MD 3 ; Susn Szpunr,

More information

Fibromuscular dysplasia (FMD) is an uncommon

Fibromuscular dysplasia (FMD) is an uncommon Top 8 Lessons Lerned From the US Registry for FMD Understnding the impct of registry dt on clinicl prctice. By Srh O Connor; Jeffrey W. Olin, DO; nd Hether L. Gornik, MD Fibromusculr dysplsi (FMD) is n

More information

Efficacy of Pembrolizumab in Patients With Advanced Melanoma With Stable Brain Metastases at Baseline: A Pooled Retrospective Analysis

Efficacy of Pembrolizumab in Patients With Advanced Melanoma With Stable Brain Metastases at Baseline: A Pooled Retrospective Analysis Efficcy of Pembrolizumb in Ptients With Advnced Melnom With Stble Brin Metstses t Bseline: A Pooled Retrospective Anlysis Abstrct 1248PD Hmid O, Ribs A, Dud A, Butler MO, Crlino MS, Hwu WJ, Long GV, Ancell

More information

T.S. Kurki a, *,U.Häkkinen b, J. Lauharanta c,j.rämö d, M. Leijala c

T.S. Kurki a, *,U.Häkkinen b, J. Lauharanta c,j.rämö d, M. Leijala c Europen Journl of Crdio-thorcic Surgery 20 (2001) 1183 1187 www.elsevier.com/locte/ejcts Evlution of the reltionship between preopertive risk scores, postopertive nd totl length of stys nd hospitl costs

More information

Supplementary Online Content

Supplementary Online Content Supplementry Online Content Rieckmnn N, Kronish IM, Shpiro PA, Whng W, Dvidson KW. Serotonin reuptke inhibitor use, depression, nd long-term outcomes fter n cute coronry : prospective cohort study. JAMA

More information

Positive Heparin-Platelet Factor 4 Antibody Complex and Cardiac Surgical Outcomes

Positive Heparin-Platelet Factor 4 Antibody Complex and Cardiac Surgical Outcomes Positive Heprin-Pltelet Fctor 4 Antibody Complex nd Crdic Surgicl Outcomes Dvid C. Kress, MD, Solomon Aronson, MD, Monic L. McDonld, MD, Mohmmd I. Mlik, MD, Ajit B. Divgi, MD, Alfred J. Tector, MD, Frncis

More information

Metabolic Syndrome and Health-related Quality of Life in Obese Individuals Seeking Weight Reduction

Metabolic Syndrome and Health-related Quality of Life in Obese Individuals Seeking Weight Reduction Metbolic Syndrome nd Helth-relted Qulity of Life in Obese Individuls Seeking Weight Reduction Adm Gilden Tsi 1, Thoms A. Wdden 1, Dvid B. Srwer 1, Robert I. Berkowitz 1, Leslie G. Womble 1, Louise A. Hesson

More information

A review of the patterns of docetaxel use for hormone-resistant prostate cancer at the Princess Margaret Hospital

A review of the patterns of docetaxel use for hormone-resistant prostate cancer at the Princess Margaret Hospital MEDICAL ONCOLOGY A review of the ptterns of docetxel use for hormone-resistnt prostte cncer t the Princess Mrgret Hospitl S.N. Chin MD,* L. Wng MSc, M. Moore MD,* nd S.S. Sridhr MD MSc* ABSTRACT Bckground

More information

PNEUMOVAX 23 is recommended by the CDC for all your appropriate adult patients at increased risk for pneumococcal disease 1,2 :

PNEUMOVAX 23 is recommended by the CDC for all your appropriate adult patients at increased risk for pneumococcal disease 1,2 : PNEUMOVAX 23 is recommended y the CDC for ll your pproprite dult ptients t incresed risk for pneumococcl disese 1,2 : Adults ged

More information

Invasive Pneumococcal Disease Quarterly Report. July September 2017

Invasive Pneumococcal Disease Quarterly Report. July September 2017 Invsive Pneumococcl Disese Qurterly Report July September 2017 Prepred s prt of Ministry of Helth contrct for scientific services by Rebekh Roos Helen Heffernn October 2017 Acknowledgements This report

More information

BENIGN ulceration along the greater curvature of the pars media of the

BENIGN ulceration along the greater curvature of the pars media of the BENIGN ULCERS OF THE GREATER CURVATURE OF THE STOMACH Report of Two Cses CHARLES H. BROWN, M.D. Deprtment of Gstroenterology nd ANTHONY D. INTRIERE, M.D.* BENIGN ulcertion long the greter curvture of the

More information

Introduction. These patients benefit less from conventional chemotherapy than patients identified as MMR proficient or microsatellite stable 3-5

Introduction. These patients benefit less from conventional chemotherapy than patients identified as MMR proficient or microsatellite stable 3-5 Nivolumb + Ipilimumb Combintion in Ptients With DNA Mismtch Repir-Deficient/Microstellite Instbility-High Metsttic Colorectl Cncer: First Report of the Full Cohort From CheckMte-142 Abstrct 553 André T,

More information

Safety and Tolerability of Subcutaneous Sarilumab and Intravenous Tocilizumab in Patients With RA

Safety and Tolerability of Subcutaneous Sarilumab and Intravenous Tocilizumab in Patients With RA Sfety nd Tolerbility of Subcutneous Srilumb nd Intrvenous Tocilizumb in Ptients With RA Pul Emery, 1 Jun Rondon, 2 Anju Grg, 3 Hubert vn Hoogstrten, 3 Neil M.H. Grhm, 4 Ming Liu, 4 Nncy Liu, 3 Jnie Prrino,

More information

Stenosis or Occlusion of the Right Subclavian and Common Carotid Arteries Is More Common than That of the Innominate Artery in Takayasu Arteritis

Stenosis or Occlusion of the Right Subclavian and Common Carotid Arteries Is More Common than That of the Innominate Artery in Takayasu Arteritis Vsculr Specilist Interntionl Vol. 31, No. 4, December 2015 pissn 2288-7970 eissn 2288-7989 Stenosis or Occlusion of the Right Subclvin nd Common Crotid Arteries Is More Common thn Tht of the Innominte

More information

Effect of Preoperative Intravenous Methocarbamol and Intravenous Acetaminophen on Opioid Use After Primary Total Hip and Knee Replacement

Effect of Preoperative Intravenous Methocarbamol and Intravenous Acetaminophen on Opioid Use After Primary Total Hip and Knee Replacement Feture Article Effect of Preopertive Intrvenous Methocrbmol nd Intrvenous Acetminophen on Opioid Use After Primry Totl Hip nd Knee Replcement THOMAS D. LOOKE, MD, PHD; CAMERON T. KLUTH, MBA bstrct Between

More information

Ann Vasc Dis Vol. 6, No. 2; 2013; pp Online April 20, Annals of Vascular Diseases doi: /avd.oa Original Article

Ann Vasc Dis Vol. 6, No. 2; 2013; pp Online April 20, Annals of Vascular Diseases doi: /avd.oa Original Article Ann Vsc Dis Vol. 6, No. 2; 2013; pp 169 174 Online April 20, 2013 2013 Annls of Vsculr Diseses doi:10.3400/vd.o.12.00085 Originl Article Protocol-Bsed Strtegy for Endovsculr Repir of Ruptured Abdominl

More information

WHEN PRECISE PLACEMENT IS CRITICAL

WHEN PRECISE PLACEMENT IS CRITICAL WHEN PRECISE PLACEMENT IS CRITICAL Stent Positioning System Ostil Pro Stent Positioning System Ostil Pro Stent Positioning System Fcilittes More Accurte Stent Positioning in AO Lesions OSTIAL PRO Stent

More information

Opioid Use and Survival at the End of Life: A Survey of a Hospice Population

Opioid Use and Survival at the End of Life: A Survey of a Hospice Population 532 Journl of Pin nd Symptom Mngement Vol. 32 No. 6 December 2006 NHPCO Originl Article Opioid Use nd Survivl t the End of Life: A Survey of Hospice Popultion Russell K. Portenoy, MD, Un Sibircev, BA,

More information

Analysis of Risk Factors for the Development of Incisional and Parastomal Hernias in Patients after Colorectal Surgery

Analysis of Risk Factors for the Development of Incisional and Parastomal Hernias in Patients after Colorectal Surgery Originl Article Journl of the Koren Society of J Koren Soc Coloproctol 2012;28(6):299-303 http://dx.doi.org/10.3393/jksc.2012.28.6.299 pissn 2093-7822 eissn 2093-7830 Anlysis of Risk Fctors for the Development

More information

A cross-sectional and follow-up study of leukopenia in tuberculosis patients: prevalence, risk factors and impact of anti-tuberculosis

A cross-sectional and follow-up study of leukopenia in tuberculosis patients: prevalence, risk factors and impact of anti-tuberculosis Originl Article A cross-sectionl nd follow-up study of leukopeni in tuberculosis ptients: prevlence, risk fctors nd impct of nti-tuberculosis tretment Fei-Shen Lin 1 *, Mei-Ying Wu 2 *, Wen-Jun Tu 3, Hong-Qiu

More information

distraction cleaning Peaks cages specifications

distraction cleaning Peaks cages specifications Peks cges specifictions We thnk for choosing Qulgenix Peks lumbr cges. 0Pwith α 8 00D8S Mteril 9 0D9S 9 be po Peks 0 - -8 0 0D0S resection with introduce remer 0DM remer 007RM Acute or chronic 0DM remer

More information

Diabetes affects 29 million Americans, imposing a substantial

Diabetes affects 29 million Americans, imposing a substantial CLINICAL Comprtive Effectiveness nd Costs of Insulin Pump Therpy for Dibetes Ronld T. Ackermnn, MD, MPH; Amish Wlli, MD, MS; Rymond Kng, MA; Andrew Cooper, MPH; Theodore A. Prospect, FSA, MAAA; Lewis G.

More information

Trends in antihypertensive and lipidlowering therapy in subjects with type II diabetes: clinical effectiveness or clinical discretion?

Trends in antihypertensive and lipidlowering therapy in subjects with type II diabetes: clinical effectiveness or clinical discretion? ORIGINAL ARTICLE Trends in ntihypertensive nd lipidlowering therpy in subjects with type II dibetes: clinicl effectiveness or clinicl discretion? MC Gulliford, J Chrlton nd R Ltinovic Deprtment of Public

More information

XII. HIV/AIDS. Knowledge about HIV Transmission and Misconceptions about HIV

XII. HIV/AIDS. Knowledge about HIV Transmission and Misconceptions about HIV XII. HIV/AIDS Knowledge bout HIV Trnsmission nd Misconceptions bout HIV One of the most importnt prerequisites for reducing the rte of HIV infection is ccurte knowledge of how HIV is trnsmitted nd strtegies

More information

Reports of cases of AIDS, HIV infection, and HIV/AIDS 1

Reports of cases of AIDS, HIV infection, and HIV/AIDS 1 Reports of cses of AIDS, HIV infection, nd HIV/AIDS 1 The HIV/AIDS Surveillnce Report is published nnully by the Division of HIV/AIDS Prevention Surveillnce nd Epidemiology, Ntionl Center for HIV, STD,

More information

Anemia in pediatric hemodialysis patients: Results from the 2001 ESRD Clinical Performance Measures Project

Anemia in pediatric hemodialysis patients: Results from the 2001 ESRD Clinical Performance Measures Project Kidney Interntionl, Vol. 64 (2003), pp. 1120 1124 Anemi in peditric hemodilysis ptients: Results from the 2001 ESRD Clinicl Performnce Mesures Project DIANE L. FRANKENFIELD, ALICA M. NEU, BRADLEY A. WARADY,

More information

The RUTHERFORD-2 trial in heterozygous FH: Results and implications

The RUTHERFORD-2 trial in heterozygous FH: Results and implications The RUTHERFORD-2 tril in heterozygous FH: Results nd implictions Slide deck kindly supplied s n eductionl resource by Professor Derick Rl MD PhD Crbohydrte & Lipid Metbolism Reserch Unit University of

More information

Changing Risk of Perioperative Myocardial Infarction

Changing Risk of Perioperative Myocardial Infarction ORIGINAL RESEARCH & CONTRIBUTIONS Chnging Risk of Periopertive Myocrdil Infrction Kenneth D Lrsen, MD, PhD; Iln S Rubinfeld, MD, MBA Perm J 2012 Fll;16(4):4-9 Abstrct Introduction: Yers go, ptients with

More information

Natural History of Left Anterior Descending Coronary Artery Obstruction: Significance of Location of Stenoses in Medically Treated Patients

Natural History of Left Anterior Descending Coronary Artery Obstruction: Significance of Location of Stenoses in Medically Treated Patients Clin. Crdiol. 8, 415-422 (1985) 0 Clinicl Crdiology Publishing Co., Inc. Originl Contributions Nturl History of Left Anterior Descending Coronry Artery Obstruction: Significnce of Loction of Stenoses in

More information

Summary of Package Insert 1

Summary of Package Insert 1 Summry of Pckge Insert 1 For Sttes with Non-Published Policies Indictions Non-infected prtil nd full-thickness skin ulcers due to VSU 2 of greter thn 1 month durtion nd which hve not dequtely responded

More information

Assessment of Depression in Multiple Sclerosis. Validity of Including Somatic Items on the Beck Depression Inventory II

Assessment of Depression in Multiple Sclerosis. Validity of Including Somatic Items on the Beck Depression Inventory II Assessment of Depression in Multiple Sclerosis Vlidity of Including Somtic Items on the Beck Depression Inventory II Peggy Crwford, PhD; Noh J. Webster, MA Signs nd symptoms of multiple sclerosis (MS)

More information

HIV Surveillance in Women. National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention Division of HIV/AIDS Prevention

HIV Surveillance in Women. National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention Division of HIV/AIDS Prevention HIV Surveillnce in Women Ntionl Center for HIV/AIDS, Virl Heptitis, STD & TB Prevention Division of HIV/AIDS Prevention Dignoses of HIV Infection mong Adult nd Adolescent Femles, by Rce/Ethnicity, 2006

More information

Cardiovascular Disease in a Forward Military Hospital during Operation Iraqi Freedom: A Report from Deployed Cardiologists

Cardiovascular Disease in a Forward Military Hospital during Operation Iraqi Freedom: A Report from Deployed Cardiologists MILITARY MEDICINE, 173, 2:193, 2008 Crdiovsculr Disese in Forwrd Militry Hospitl during Opertion Irqi Freedom: A Report from Deployed Crdiologists MAJ Lnce Sullenberger, MC USA*; MAJ Philip J. Gentlesk,

More information

SUSPECT ADVERSE REACTION REPORT

SUSPECT ADVERSE REACTION REPORT CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16390235 I. REACTION INFORMATION 1. PATIENT INITIALS 1. COUNTRY 2. DATE OF BIRTH 2. AGE 3. SEX 4-6 REACTION ONSET privcy (10000059): Abdominl discomfort

More information

Urinary Tract Infection in Men

Urinary Tract Infection in Men C H A P T E R 1 9 Urinry Trct Infection in Men Toms L. Griebling, MD Associte Professor & Vice Chir of Urology University of Knss Knss City, Knss Contents INTRODUCTION........................................623

More information

msmr MEDICAL SURVEILLANCE MONTHLY REPORT INSIDE THIS ISSUE: A publication of the Armed Forces Health Surveillance Center Summary tables and figures

msmr MEDICAL SURVEILLANCE MONTHLY REPORT INSIDE THIS ISSUE: A publication of the Armed Forces Health Surveillance Center Summary tables and figures VOL. 17 NO. 09 SEPTEMBER 2010 msmr A publiction of the Armed Forces Helth Surveillnce Center MEDICAL SURVEILLANCE MONTHLY REPORT Source: CDC INSIDE THIS ISSUE: Contct trnsfer of vccini virus from U.S.

More information

University of Texas Health Science Center, San Antonio, San Antonio, Texas, USA

University of Texas Health Science Center, San Antonio, San Antonio, Texas, USA Lung Cncer Chemotherpy Given Ner the End of Life by Community Oncologists for Advnced Non-Smll Cell Lung Cncer Jose R. Murillo, Jr., Jim Koeller b,c Methodist Hospitl, Houston, Texs, USA; b University

More information

Efficacy of Sonidegib in Patients With Metastatic BCC (mbcc)

Efficacy of Sonidegib in Patients With Metastatic BCC (mbcc) AAD 216 eposter 3368 Efficcy of Sonidegib in Ptients With Metsttic BCC (mbcc) Colin Morton, 1 Michel Migden, 2 Tingting Yi, 3 Mnish Mone, 3 Dlil Sellmi, 3 Reinhrd Dummer 4 1 Stirling Community Hospitl,

More information

Impact of left ventricular hypertrophy on survival in end-stage renal disease

Impact of left ventricular hypertrophy on survival in end-stage renal disease Kidney Interntionl, Vol. 36 (1989), pp. 286 290 Impct of left ventriculr hypertrophy on survivl in end-stge renl disese JONATHAN S. SILBERBERG, PAUL E. BARRE, SARAH S. PRICHARD, nd ALLAN D. SNIDERMAN Divisions

More information

Retrospective Study of Postoperative Pulmonary Complications in Patients with Cervical Spine Pathology

Retrospective Study of Postoperative Pulmonary Complications in Patients with Cervical Spine Pathology 98 Pulmonry Originl Article Compliction fter Cervicl Spine Surgery THIEME Retrospective Study of Postopertive Pulmonry Complictions in Ptients with Cervicl Spine Pthology Sury Kumr Dube 1 Mihir Prksh Pndi

More information

Refining Clinical Risk Stratification for Predicting Stroke and Thromboembolism in Atrial Fibrillation Using a Novel Risk Factor-Based Approach

Refining Clinical Risk Stratification for Predicting Stroke and Thromboembolism in Atrial Fibrillation Using a Novel Risk Factor-Based Approach CHEST Originl Reserch Refining Clinicl Risk Strtifiction for Predicting Stroke nd Thromboembolism in Atril Fibrilltion Using Novel Risk Fctor-Bsed Approch The Euro Hert Survey on Atril Fibrilltion THROMBOEMBOLISM

More information

Risks for All-Cause Mortality: Stratified by Age, Estimated Glomerular Filtration Rate and Albuminuria

Risks for All-Cause Mortality: Stratified by Age, Estimated Glomerular Filtration Rate and Albuminuria Clinicl Prctice: Mini-Review Received: My 20, 2016 Accepted fter revision: December 14, 2016 Published online: Jnury 27, 2017 Risks for All-Cuse Mortlity: Strtified by Age, Estimted Glomerulr Filtrtion

More information

Original Article. T Akter 1, N Islam 2, MA Hoque 3, S Khanam 4, HA khan 5, BK Saha 6. Abstract:

Original Article. T Akter 1, N Islam 2, MA Hoque 3, S Khanam 4, HA khan 5, BK Saha 6. Abstract: Fridpur Med. Coll. J. 214;9(2):61-67 Originl Article Nebuliztion by Isotonic Mgnesium Sulphte Solution with Provide Erly nd Better Response s Compred to Conventionl Approch ( Plus Norml Sline) in Acute

More information

Perioperative Hyperglycemia and Postoperative Infection after Lower Limb Arthroplasty

Perioperative Hyperglycemia and Postoperative Infection after Lower Limb Arthroplasty Journl of Dibetes Science nd Technology Volume 5, Issue 2, Mrch 2011 Dibetes Technology Society ORIGINAL ARTICLES Periopertive Hyperglycemi nd Postopertive Infection fter Lower Limb Arthroplsty Boris,

More information

METHOD 4010 SCREENING FOR PENTACHLOROPHENOL BY IMMUNOASSAY

METHOD 4010 SCREENING FOR PENTACHLOROPHENOL BY IMMUNOASSAY METHOD 4010 SCREENING FOR PENTACHLOROPHENOL BY IMMUNOASSAY 1.0 SCOPE AND APPLICATION 1.1 Method 4010 is procedure for screening solids such s soils, sludges, nd queous medi such s wste wter nd lechtes

More information

Hepatitis A virus (HAV) infection contributes approximately

Hepatitis A virus (HAV) infection contributes approximately Multiple Fctors Contribute to Positive Results for Heptitis A Virus Immunoglobulin M Antibody Adnn Altoom, MD, PhD; M. Qsim Ansri, MD; Jennifer Cuthbert, MD Context. In the United Sttes, successful vccintion

More information

Start ORKAMBI today. INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION. Sydney Age 4

Start ORKAMBI today. INDICATIONS AND USAGE IMPORTANT SAFETY INFORMATION. Sydney Age 4 F O R H E A L T H C A R E P R O F E S S I O N A L S For ptients ge 2 yers nd older who re homozygous for the F508del muttion 1,2 Modify the course. Strt tody. Sydney Age 4 F508del/F508del INDICATIONS AND

More information

Appendix J Environmental Justice Populations

Appendix J Environmental Justice Populations Appendix J Environmentl Justice s [This pge intentionlly left blnk] Tble of Contents REFERENCES...J-2 Pge LIST OF TABLES Pge Tble J-1: Demogrphic Overview of Bruinsburg Site Project Are... J-3 Tble J-2:

More information

Relationship Between Hospital Performance on a Patient Satisfaction Survey and Surgical Quality

Relationship Between Hospital Performance on a Patient Satisfaction Survey and Surgical Quality Reserch Originl Investigtion Reltionship Between Hospitl Performnce on Ptient Stisfction Survey nd Surgicl Qulity Greg D. Scks, MD, MPH; Elise H. Lwson, MD, MSHS; Aron J. Dwes, MD; Mrci M. Russell, MD;

More information

Report of the Conference on Low Blood

Report of the Conference on Low Blood 1046 Report of the Conference on Low Blood Cholesterol: Mortlity Associtions Dvid Jcobs, PhD; Henry Blckburn, MD; Millicent Higgins, MD; Dwyne Reed, MD, PhD; Hiroysu Iso, MD; Grdner McMilln, MD, PhD; Jmes

More information

Presented at the 75 th Annual Meeting of the American Academy of Dermatology, Orlando, FL, March 3-7, 2017 METHODS INTRODUCTION OBJECTIVE

Presented at the 75 th Annual Meeting of the American Academy of Dermatology, Orlando, FL, March 3-7, 2017 METHODS INTRODUCTION OBJECTIVE Seven-Yer Interim Results from the ESPRIT 10-Yer Postmrketing Surveillnce Registry of Adlimumb for Moderte to Severe Psorisis Frncisco Kerdel, 1 Aln Menter, 2 Jshin J. Wu, 3 Mreike Bereswill, 4 Dilek Arikn,

More information

Using Paclobutrazol to Suppress Inflorescence Height of Potted Phalaenopsis Orchids

Using Paclobutrazol to Suppress Inflorescence Height of Potted Phalaenopsis Orchids Using Pcloutrzol to Suppress Inflorescence Height of Potted Phlenopsis Orchids A REPORT SUBMITTED TO FINE AMERICAS Linsey Newton nd Erik Runkle Deprtment of Horticulture Spring 28 Using Pcloutrzol to Suppress

More information

The Centers for Disease

The Centers for Disease originlcontributions Evluting the HIV Continuum of Cre within Lrge Integrted Helth System by Michel J. Willims, PhrmD nd Thoms J. Dilworth, PhrmD Abstrct Objective: The primry study objective ws to describe

More information

Addendum to the Evidence Review Group Report on Aripiprazole for the treatment of schizophrenia in adolescents (aged years)

Addendum to the Evidence Review Group Report on Aripiprazole for the treatment of schizophrenia in adolescents (aged years) Addendum to the Evidence Review Group Report on Aripiprzole for the tretment of schizophreni in dolescents (ged 15-17 yers) Produced by Authors Correspondence to Southmpton Helth Technology Assessments

More information

Metformin and breast cancer stage at diagnosis: a population-based study

Metformin and breast cancer stage at diagnosis: a population-based study ORIGINAL ARTICLE METFORMIN AND BREAST CANCER STAGE AT DIAGNOSIS, Leg et l. Metformin nd brest cncer stge t dignosis: popultion-bsed study I.C. Leg md msc,* K. Fung msc,* P.C. Austin phd, nd L.L. Lipscombe

More information

Invasive Pneumococcal Disease Quarterly Report July September 2018

Invasive Pneumococcal Disease Quarterly Report July September 2018 Invsive Pneumococcl Disese Qurterly Report July Septemer Introduction Since 17 Octoer 2008, invsive pneumococcl disese (IPD) hs een notifile to the locl Medicl Officer of Helth under the Helth Act 1956.

More information

European Journal of Internal Medicine

European Journal of Internal Medicine Europen Journl of Internl Medicine 22 (2011) 399 406 Contents lists vilble t ScienceDirect Europen Journl of Internl Medicine journl homepge: www.elsevier.com/locte/ejim Originl rticle Incidence of cute

More information

Staged carotid and coronary surgery for concomitant carotid and coronary artery disease

Staged carotid and coronary surgery for concomitant carotid and coronary artery disease Europen Journl of Crdio-thorcic Surgery 21 (2002) 181 186 www.elsevier.com/locte/ejcts Stged crotid nd coronry surgery for concomitnt crotid nd coronry rtery disese Pedro E. Antunes, Gbriel Ancleto, J.M.

More information

Lung cancer is the leading cause of cancer-related deaths in

Lung cancer is the leading cause of cancer-related deaths in ORIGINAL ARTICLE Resection Rte nd Outcome of Pulmonry Resections for Non Smll-Cell Lung Cncer A Ntionwide Study From Icelnd Hunbogi Thorsteinsson, MD,* Asgeir Alexndersson, MD,* Gudrun N. Oskrsdottir,

More information

Preoperative prediction of prolonged mechanical ventilation following coronary artery bypass grafting

Preoperative prediction of prolonged mechanical ventilation following coronary artery bypass grafting Europen Journl of Crdio-thorcic Surgery 20 (2001) 930 936 www.elsevier.com/locte/ejcts Preopertive prediction of prolonged mechnicl ventiltion following coronry rtery bypss grfting Abstrct J.F. Légré,

More information

EFFECTS OF INGREDIENT AND WHOLE DIET IRRADIATION ON NURSERY PIG PERFORMANCE

EFFECTS OF INGREDIENT AND WHOLE DIET IRRADIATION ON NURSERY PIG PERFORMANCE Swine Dy 21 EFFECTS OF INGREDIENT AND WHOLE DIET IRRADIATION ON NURSERY PIG PERFORMANCE J. M. DeRouchey, M. D. Tokch, J. L. Nelssen, R. D. Goodbnd, S. S. Dritz 1, J. C. Woodworth, M. J. Webster, B. W.

More information

3.3 Verotoxigenic E. coli

3.3 Verotoxigenic E. coli 3.3 Verotoxigenic E. coli Summry Number of VTEC cses, 215: 73 Crude incidence rte, 215: 15.9/1, Number of VTEC-ssocited HUS, 215: 22 Number of VTEC cses, 214: 77 Introduction For mny yers, Irelnd hs the

More information

Division of Endocrinology and Metabolism, Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, 2

Division of Endocrinology and Metabolism, Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, 2 Originl Article Epidemiology http://dx.doi.org/1.493/dmj.214.38.1.51 pissn 2233-679 eissn 2233-687 DIABETES & METABOLISM JOURNAL Higher Prevlence nd Awreness, but Lower Control Rte of Hypertension in Ptients

More information

of comorbid conditions, interventions Diagnosis and treatment, treatment reduction of risk factors for CVD to slow disease progression,

of comorbid conditions, interventions Diagnosis and treatment, treatment reduction of risk factors for CVD to slow disease progression, Tble 5.1. NKF Clssifiction of Chronic Kidney Disese nd Clinicl Fetures Stge Description GFR (ml/ min/1.73 m 2 ) U.S. Prevlence, b # Affected (%) Clinicl Fetures Action Pln c At incresed risk for CKD >60

More information

Results. Table 1: Demographic and Baseline Characteristics, Open-Label Safety Population Prior Double-Blind OC/APAP ER (n=77)

Results. Table 1: Demographic and Baseline Characteristics, Open-Label Safety Population Prior Double-Blind OC/APAP ER (n=77) Open-Lbel Extension of Rndomized, Double-Blind, Plcebo-Controlled, Phse 3 Study of the Sfety nd Anlgesic Efficcy of MNK-795 Oxycodone/Acetminophen Extended-Relese (OC/APAP ER) Tblets in n Acute Pin Model

More information

Perforation Following Colorectal Endoscopy: What Happens Beyond the Endoscopy Suite?

Perforation Following Colorectal Endoscopy: What Happens Beyond the Endoscopy Suite? credits vilble for this rticle see pge 88. Originl RESEARCH & CONTRIBUTIONS Perfortion Following Colorectl Endoscopy: Wht Hppens Beyond the Endoscopy Suite? Michel S Tm, MD; Mher A Abbs, MD, FACS, FASCRS

More information

Single-Molecule Studies of Unlabelled Full-Length p53 Protein Binding to DNA

Single-Molecule Studies of Unlabelled Full-Length p53 Protein Binding to DNA Single-Molecule Studies of Unlbelled Full-Length p53 Protein Binding to DNA Philipp Nuttll, 1 Kidn Lee, 2 Pietro Ciccrell, 3 Mrco Crminti, 3 Giorgio Ferrri, 3 Ki- Bum Kim, 2 Tim Albrecht 1* 1 Imperil College

More information

A community-based comparison of trauma patient outcomes between D- and L-lactate fluids,

A community-based comparison of trauma patient outcomes between D- and L-lactate fluids, Americn Journl of Emergency Medicine (2013) 31, 206 214 www.elsevier.com/locte/jem Originl Contribution A community-bsed comprison of trum ptient outcomes between D- nd L-lctte fluids, Kzuki Kuwbr PhD,,

More information

University of Cape Town

University of Cape Town .. I i I II I I The copyright of this thesis vests in the uthor. No quottion from it or informtion derived from it is to be published without full cknowledgement of the source. The thesis is to be used

More information

Lung cancer is the leading cause of cancer death worldwide, EGFR Mutation and Brain Metastasis in Pulmonary Adenocarcinomas

Lung cancer is the leading cause of cancer death worldwide, EGFR Mutation and Brain Metastasis in Pulmonary Adenocarcinomas Originl Article EGFR Muttion nd Brin Metstsis in Pulmonry Adenocrcinoms Dong-Yeop Shin, MD,* Im Il N, MD,* Cheol Hyeon Kim, MD, PhD, Sunhoo Prk, MD, PhD, HeeJong Bek, MD, PhD, nd Sung Hyun Yng, MD, PhD*

More information

Radiation therapy (RT) for cancer that involves the thorax

Radiation therapy (RT) for cancer that involves the thorax Originl Article Prospective Explortory Anlysis of Crdic Biomrkers nd Electrocrdiogrm Abnormlities in Ptients Receiving Thorcic Rdition Therpy with High-Dose Hert Exposure Dniel R. Gomez, MD,* Syed Wmique

More information

A survey of atrial fibrillation in general practice: the West Birmingham Atrial Fibrillation Project

A survey of atrial fibrillation in general practice: the West Birmingham Atrial Fibrillation Project Originl ppers A survey of tril fibrilltion in generl prctice: the West Birminghm Atril Fibrilltion Project GREGORY Y H LIP DANIEL J GOLDING MASOOD NAZIR D GARETH BEEVERS DAVID L CHILD R IAN FLETCHER SUMMARY

More information

Seasonal influenza vaccination programme country profile: Ireland

Seasonal influenza vaccination programme country profile: Ireland Sesonl influenz vccintion progrmme country profile: Irelnd 2012 13 Seson Bckground informtion Influenz immunistion policy nd generl fcts bout Irelnd Volume indices of GDP per cpit in 2011 nd 2013 (EU-

More information

Sponsor / Company: Sanofi Drug substance(s): AVE0005 (aflibercept)

Sponsor / Company: Sanofi Drug substance(s): AVE0005 (aflibercept) These results re supplied for informtionl purposes only. Prescribing decisions should be mde bsed on the pproved pckge insert in the country of prescription. Sponsor / Compny: Snofi Drug substnce(s): AVE0005

More information

Abstract. Background. Aim. Patients and Methods. Patients. Study Design

Abstract. Background. Aim. Patients and Methods. Patients. Study Design Impct of the Use of Drugs nd Substitution Tretments on the Antivirl Tretment of Chronic Heptitis C: Anlysis of Complince, Virologicl Response nd Qulity of Life (CHEOBS). Melin, 1 J.-. Lng, D. Ouzn, 3 M.

More information

Inhaled Corticosteroid Is Associated With an Increased Risk of TB in Patients With COPD

Inhaled Corticosteroid Is Associated With an Increased Risk of TB in Patients With COPD CHEST Originl Reserch Inhled Corticosteroid Is Associted With n Incresed Risk of TB in Ptients With COPD Jung-Hyun Kim, MD ; Ji-Soo Prk, MD ; Kyung-Ho Kim, MD ; Hye-Cheol Jeong, MD ; Eun-Kyung Kim, MD

More information

Summary. Effect evaluation of the Rehabilitation of Drug-Addicted Offenders Act (SOV)

Summary. Effect evaluation of the Rehabilitation of Drug-Addicted Offenders Act (SOV) Summry Effect evlution of the Rehbilittion of Drug-Addicted Offenders Act (SOV) The Rehbilittion of Drug-Addicted Offenders Act (SOV) ws lunched on April first 2001. This lw permitted the compulsory plcement

More information

R Martino 1, P Romero 1, M Subirá 1, M Bellido 1, A Altés 1, A Sureda 1, S Brunet 1, I Badell 2, J Cubells 2 and J Sierra 1

R Martino 1, P Romero 1, M Subirá 1, M Bellido 1, A Altés 1, A Sureda 1, S Brunet 1, I Badell 2, J Cubells 2 and J Sierra 1 Bone Mrrow Trnsplnttion, (1999) 24, 283 287 1999 Stockton Press All rights reserved 0268 3369/99 $12.00 http://www.stockton-press.co.uk/bmt Comprison of the clssic Glucksberg criteri nd the IBMTR Severity

More information

Fat intake in patients newly diagnosed with type 2 diabetes: a 4-year follow-up study in general practice

Fat intake in patients newly diagnosed with type 2 diabetes: a 4-year follow-up study in general practice Originl ppers Ft intke in ptients newly dignosed with type 2 dibetes: 4-yer follow-up study in generl prctice Floris A vn de Lr, Eloy H vn de Lisdonk, Peter L B J Lucssen, J M H Tigchelr, Sski Meyboom,

More information

key words: chronic obstructive pulmonary disease, beta agonists, Medicare, health care costs, health care utilization

key words: chronic obstructive pulmonary disease, beta agonists, Medicare, health care costs, health care utilization reserch report Helth Cre Use nd Costs Among Medicre Ptients With Chronic Obstructive Pulmonry Disese Treted With Short-Acting Bet Agonists or Long-Acting Bet Agonists Flvi Ejzykowicz, PhD; 1 Vmsi K Bollu,

More information

Potential for Interactions Between Dietary Supplements and Prescription Medications a

Potential for Interactions Between Dietary Supplements and Prescription Medications a CLINICAL RESEARCH STUDY Potentil for Interctions Between Dietry Supplements nd Prescription Medictions Amit Sood, MD, MSc, Rich Sood, MD, b Frncis J. Brinker, ND, Rvneet Mnn, MBBS, c Lur L. Loehrer, Dietlind

More information

Recall Bias in Childhood Atopic Diseases Among Adults in The Odense Adolescence Cohort Study

Recall Bias in Childhood Atopic Diseases Among Adults in The Odense Adolescence Cohort Study Syddnsk Universitet Recll Bis in Childhood Atopic Diseses Among Adults in The Odense Adolescence Cohort Study Mørtz, Chrlotte G; Andersen, Klus Ejner; Bindslev-Jensen, Crsten Published in: Act Dermto-Venereologic

More information

Target: 10 mg/day within several days Schizophrenia in adolescents (2.1)

Target: 10 mg/day within several days Schizophrenia in adolescents (2.1) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include ll the informtion needed to use ZYPREXA sfely nd effectively. See full prescribing informtion for ZYPREXA. ZYPREXA (olnzpine) Tblet

More information

Relation of Tumor Size, Lymph Node Status, and Survival in

Relation of Tumor Size, Lymph Node Status, and Survival in Reltion of Tumor Size, Lymph Node Sttus, nd Survivl in 24,74 Brest Cncer Cses CHRISTINE L. CARTER, PHD, MPH,* CAROL ALLEN, PHD,t AND DONALD E. HENSON, MD* Two of the most importnt prognostic indictors

More information

Patient Survival After Surgical Treatment of Rectal Cancer

Patient Survival After Surgical Treatment of Rectal Cancer Originl Article Ptient Survivl After Surgicl Tretment of Rectl Cncer Impct of Surgeon nd Hospitl Chrcteristics Dvid A. Etzioni, MD, MSHS 1,2 ; Toni M. Young-Fdok, MD, MS 1 ; Robert R. Cim, MD, MA 2,3 ;

More information