2015 Clinical Update Endovascular Systems for AAA Repair

Transcription

1 Endovascular Systems for AAA Repair 2 Musick Irvine, CA Tel Fax

2 TABLE OF CONTENTS Section Page ABSTRACT... 3 READER S GUIDE... 4 SECTION 1: US PIVOTAL CLINICAL STUDIES... 8 Patient Status and Accountability... 9 Aneurysm-Related Mortality All-Cause Mortality Major Adverse Events Treatment Effectiveness Aneurysm Sac Exclusion Migration Endoleak Incidence Secondary Interventions Device Integrity Summary Future Plans SECTION 2: COMMERCIAL EXPERIENCE Aneurysm-Related Mortality and Surgical Conversion Aneurysm Rupture Post-Procedure Endoleak Device Integrity Commercial Experience Summary SECTION 3: DEVICE EXPLANT EVALUATIONS SECTION 4: NOTES TO CLINICIANS SECTION 5: BRIEF SUMMARY OF INDICATIONS, WARNINGS AND PRECAUTIONS FROM IFU MM1059 Rev 01 2

3 ABSTRACT This report provides a current summary of long-term clinical experience for the Endologix studies for endovascular abdominal aortic aneurysm (AAA) repair with the Endologix Powerlink and AFX stent graft systems. Five US clinical studies involving 726 patients have been performed and results submitted to the US FDA to support marketing approvals. This includes the Infrarenal Bifurcated study, Suprarenal Bifurcated study, XL Aortic Extension study, Suprarenal Aortic Extension study, and the PEVAR Trial. In addition, post-marketing information is included regarding worldwide commercial experience, trends, and new or improved devices since the original FDA approval. In the five-year follow-up of the Bifurcated studies, both test and open surgical control patients were evaluated. Primary endpoint follow-up for patients enrolled in all five studies was completed and approved by the US FDA. The Kaplan-Meier five-year estimates in the Infrarenal Test, Suprarenal Test, and Surgical Control groups, respectively, are: 98%, 98%, and 94% (freedom from aneurysm-related mortality); 77%, 77%, and 73% (freedom from all-cause mortality); and 47%, 53%, and 58% (freedom from major adverse events). The XL and Suprarenal aortic extension devices were approved based upon pivotal study endpoint results of the prospective multi-center studies in which all patients received the bifurcated device via anatomical fixation at the aortoiliac bifurcation, and either the XL aortic extension or suprarenal aortic extension placed proximally to achieve seal. At one year, freedom from aneurysm-related mortality, conversion to open repair, and migration in both studies was 100%. Five-year follow-up for patients enrolled in the XL and Suprarenal Aortic Extension studies is complete. The PEVAR Trial is the first multicenter, prospective, randomized trial of percutaneous endovascular aneurysm repair, and used the Endologix stent graft device for the endovascular repair. Femoral artery access was obtained using totally percutaneous techniques with suture-mediated closure devices, or using standard femoral exposure. The 1-month Treatment Success primary endpoint results of this trial demonstrated non-inferiority of PEVAR (facilitated with the Abbott Vascular, Inc. ProGlide device) in comparison to EVAR with standard femoral exposure. Final six-month follow-up for patients enrolled in the PEVAR Trial is complete. In summary, Core Laboratory evaluations of CT scans and x-rays have revealed no aneurysm rupture, stent fracture, or graft holes in any subject enrolled in the clinical studies of AAA repair with the Endologix Stent Graft Systems. Limited device migration has been observed, and endoleaks have been primarily identified as Type II, with a low incidence of Type I proximal or distal endoleak. Among all test patients who received the bifurcated device, 100% freedom from aneurysm-related mortality is observed. Moreover, a progressive reduction in mean aneurysm sac diameter is observed at each completed follow-up interval, with the large majority of patients exhibiting a significantly decreased or stable aneurysm size. The commercial experience related to aneurysm-related mortality among intraoperative and postoperative reports observed globally (more than 151,000 devices distributed) is consistent with the controlled clinical study experience. Improvements have been made to the delivery system to mitigate potential risks and to proactively respond to customer feedback. In mid-2011, Endologix introduced the AFX Endovascular AAA System which integrates a low profile, hydrophilically-coated 17Fr introducer system with AFX delivery systems, standard 9Fr percutaneous, pre-cannulated contralateral access, and stent grafts ranging in diameter from 22 to 34mm proximally and 13 to 25mm distally featuring proprietary eptfe graft technology. Additional improvements include the Vela Proximal Endograft System with radiopaque marker and improved delivery control and introduction of Duraply graft material with enhanced strength properties, both introduced in MM1059 Rev 01 3

4 READER S GUIDE Endologix, Inc. has prepared this clinical update to provide current information on the worldwide experience to date to physician users. Data and information on the final follow-up on the test patients implanted with the device during the original studies and on surgical control patients is detailed, including patient accountability, adverse events, incidence of endoleak, and aneurysm sac diameter regression. In addition, worldwide post-market information pertaining to product use, safety, and performance are discussed. A brief summary of the stent graft and delivery system design and construction as well as the regulatory status is provided below. The remainder of this section provides an overview of the contents of this report. Device Description The Endologix Powerlink and AFX stent graft systems are indicated for the endovascular treatment of abdominal aortic aneurysm (AAA) using a surgical vascular access technique or a bilateral percutaneous technique in patients having suitable anatomy, including an adequate proximal aortic neck seal zone and common iliac artery seal zones. When deployed across the aortic aneurysm, the self-expanded stent graft implant provides a permanent conduit for blood flow, excluding the aneurysm sac from blood flow and pressurization. Refer to the Instructions for Use for all indications, contraindications, warnings, precautions, and details for proper use of the device. In recent years, Endologix has made several important improvements to the AFX stent graft family: 1. The Vela Proximal Endograft System was introduced for suprarenal and infrarenal proximal stent graft devices in February The stent graft was improved with the addition of a radiopaque marker within the proximal edge of the stent graft; this enhances fluoroscopic visualization during placement of the graft-covered device below the most caudal renal artery. The delivery system was improved with the addition of an internal constraining sleeve and refinements to the deployment mechanism, which enable further physician control over the stent graft deployment process to aid in precise placement at the desired location. 2. A change to the expanded polytetrafluoroethylene (eptfe) graft processing methods was introduced in October 2014 which results in an ultra-high-density, multi-layered material referred to as Duraply. This improvement increased the graft material strength unilaterally while preserving the material s biocompatibility profile, and all other conformability and mechanical characteristics. 3. AFX Instructions for Use (IFU) were updated in 2015 to further clarify existing information related to procedure planning and follow-up imaging, and to improve the instructions for Vela deployment and delivery system withdrawal. Updates focused mainly on factors related to Type III endoleak prevention and monitoring; strengthening warnings/precautions, clarifying patient selection/treatment approach, and recommendations for imaging and post-operative patient follow-up. The imaging guidelines section was updated to include factors specific to Type III endoleak identification, including reduction in overlap and device integrity verification. 4. The AFX2 Bifurcated Endograft System is FDA and CE Mark approved. AFX2 consists of a new delivery system that features an integrated contralateral wire to replace the previous wire, refinement of the hemostatic control within the handle, and reduction of the contralateral introducer from 9F to a 7F profile. The inclusion of a contralateral.035" wire eliminates the previous contralateral wire exchange reducing both the number and complexity of steps in deployment. AFX2 is expected to be introduced in the U.S. and international markets in MM1059 Rev 01 4

5 The Endologix unibody infrarenal bifurcated stent grafts (primary device) has a main body with two attached limbs. Accessory stent grafts for customization to the patient anatomy are comprised of infrarenal and suprarenal proximal extensions and limb extensions in straight, tapered, flared, and stepped configurations. Both Powerlink and AFX stent grafts are constructed from the same cobalt chromium alloy stent cage. The high density expanded polytetrafluoroethylene (eptfe) graft cover used in the AFX stent graft evolved from a process improvement which reduced the Powerlink eptfe graft material thickness by half while maintaining the same mechanical strength and durability specifications to allow for a reduction delivery system profile. Surgical suture attaches the bifurcated body and limb grafts, and attaches the graft to the stent at each end. In the suprarenal configuration, a 2cm-length bare stent segment is attached to the proximal end of the stent graft. The bifurcated and proximal extension stent graft configurations are depicted in Figure 1. The limb extension stent graft configurations are shown in Figure 2. Figure 1. Bifurcated and Proximal Extension Stent Graft Configurations Infrarenal Bifurcated Stent Graft Infrarenal Proximal Extension Stent Graft Suprarenal Proximal Extension Stent Graft Figure 2. Limb Extension Stent Graft Configurations Straight and Tapered Limb Extension Stent Grafts Flared and Stepped Limb Extension Stent Grafts Placement of the long main body of the bifurcated stent graft with attached limbs at the aortoiliac bifurcation serves as the foundation for the implant by providing columnar support in the aneurysm sac, directly absorbing the luminal blood flow at the natural anatomical bifurcation, and eliminating the need for stent graft fixation within the proximal neck. The proximal extension and limb extension stent grafts permit customization of the implant to the patient anatomy as required, accommodating a range of proximal neck and iliac diameters. MM1059 Rev 01 5

6 The AFX Endograft AAA System is used with a separate 17Fr AFX Introducer System (19Fr outside diameter). All AFX stent graft delivery systems are compatible with the AFX Introducer System. There are three types of stent graft delivery systems that require delivery through the introducer system: the bifurcated stent graft delivery system; the Vela Proximal Endograft System, and the standard limb extension delivery system. A lower profile limb extension delivery system in 14 or 16Fr outer profile may be used alone or in conjunction with the introducer system. Only one femoral access site compatible with the 17Fr introducer sheath is required for ipsilateral deployment; contralateral access is compatible with standard percutaneous 9Fr introducers for the current AFX Bifurcated Endograft delivery system and reduces to 7Fr with the forthcoming AFX2 Bifurcated Endograft System. Introduction Endologix is dedicated to putting patients first in all we do. Central to this core value is our commitment to provide updated and emerging data and information to the physicians who care for these patients on our products and their safety and performance profiles. This 2015 annual update marks the 11-year anniversary of the initial US Food and Drug Administration (FDA) premarket approval of our Powerlink System, which is also available internationally in various countries. The AFX System has been available in the US since FDA approval in It was introduced in Europe shortly after the US introduction, and is available internationally in various countries. The results contained in this report indicate that the Powerlink and AFX Systems provide a safe and effective endovascular aneurysm repair (EVAR) stent graft option in appropriately selected patients. Section 1 presents the long-term, final follow-up results from the five US pivotal clinical studies conducted with the Powerlink stent graft: the Infrarenal Bifurcated study, Suprarenal Bifurcated study, and XL study (34mm proximal extension), Suprarenal Extension study, and PEVAR (totally percutaneous EVAR) Trial. Safety results presented include the incidence of major adverse events as prospectively defined in the study protocols. Kaplan-Meier estimates for freedom from major adverse events, freedom from all-cause mortality, and freedom from aneurysm-related mortality are also presented. Effectiveness results include primary performance measures, and Core Laboratory reported aneurysm morphology evaluations, migration, endoleak incidence, secondary interventions, and stent graft performance measures including device patency, stent fracture, and graft integrity. Early, mid- and long-term follow-up results from the studies are positive. Moreover, results are consistent between studies, providing additional validating evidence as to the conclusions that can be drawn from the study results. In the Infrarenal and Suprarenal Bifurcated studies, results within one year demonstrate reduced incidence of major adverse events compared to the surgical control group. Continued follow-up through five years finds no significant differences between groups. Among all test patients, no aneurysm rupture was observed. Kaplan-Meier estimates for Infrarenal and Suprarenal test patients, respectively, include freedom from major adverse events (47%, 53%); freedom from all-cause mortality (77%, 77%); and freedom from aneurysmrelated mortality (98%, 98%). Aneurysm size is stable or decreased in the majority of patients, and mean sac diameter continued to decrease over time in the test groups. Secondary interventions within five years were performed primarily for Type II endoleak, with low rates of device-related interventions for endoleak or limb occlusion. No aneurysm rupture, stent fracture, graft failure, or other significant device integrity loss was observed through the five-year follow-up. No aneurysm-related mortality was observed in the XL and suprarenal aortic extension studies, which prospectively studied the anatomical fixation algorithm of the Endologix endografts. Unique to our platform, the bifurcated device with long main body was placed at the aortoiliac bifurcation with the long main body across the aneurysm; a proximal extension of suitable diameter was then placed to achieve both significant overlap with the bifurcated device body and proximal seal in the infrarenal neck. Aneurysm size is stable or MM1059 Rev 01 6

7 decreased in the majority of patients, and mean sac diameter continued to decrease over time. Secondary interventions within five years were performed primarily for Type II endoleak, with low rates of device-related interventions for endoleak or limb occlusion. No aneurysm rupture, stent fracture, graft failure, or other significant device integrity loss was observed through final five-year follow-up. No aneurysm-related deaths were observed in the PEVAR trial among 100 patients randomized to either totally percutaneous access or standard femoral exposure and endovascular repair using the Powerlink endografts. Treatment Success at one month, defined as procedural technical success per randomized assignment and absence of major adverse event or vascular event, was 88% and 78% in the PEVAR/ProGlide and SEVAR groups, respectively. No aneurysm rupture, stent fracture, graft failure, or other significant device integrity loss was observed through final six month follow-up. Section 2 presents the worldwide post-marketing experience. A total of 151,652 devices have been distributed globally since initial marketing. Endologix maintains an active system for collection, monitoring, and handling of customer experience reports (complaints) for its devices marketed worldwide. Integral to this system is the reporting of events in accordance with US regulations under 21 CFR 803 (Medical Device Reporting) and international Vigilance reporting requirements. Post-market surveillance has served to verify the effectiveness of the training program, and provided confirmation of elements of the approved labeling intended to mitigate risks. Such elements include: Identification and selection of suitable patient anatomy; Proper aneurysm and vascular sizing based on a recent high-resolution, contrast-enhanced computed tomography (CT) scan; Proper stent graft selection and placement for the vascular and aneurysm anatomy being treated; Use and maintenance of a stiff guidewire during device delivery and deployment; Identification and use of radiopaque markers during placement, deployment, and delivery system removal. Section 3 provides a summary of all explant analyses from the pivotal clinical studies, as well as from commercial experience. Analyses included evaluation of the explanted stent graft using standa rd techni ques. Histopathological analyses were conducted by an independent, qualified laboratory. Section 4 provides Notes to Clinicians on the AFX System, and discusses important information on patient selection, device selection, and patient follow-up recommendations, including imaging assessments. Section 5 provides a brief summary of the product indications, contraindications, warnings, and precautions; it also provides information on the peer-reviewed published literature of Powerlink and AFX outcomes to further inform physician decision making in caring for patients with AAA. MM1059 Rev 01 7

8 SECTION 1: US Pivotal Clinical Trials Endologix has completed five US pivotal clinical studies of the Powerlink System for endovascular AAA repair that were the basis for determinations of reasonable assurances of safety and effectiveness by the US Food and Drug Administration: Infrarenal Bifurcated Study: This multicenter, prospective, concurrently controlled clinical study compared 192 standard risk patients with anatomy suitable for endovascular repair to 66 patients treated with open surgery. Patients were enrolled between July 2000 and March 2003, and per the originally approved protocol and patient consent, were followed to the primary one year timepoint with continued long-term follow-up commitment. An independent data safety monitoring board (DSMB) reviewed the results of this study and recommended study continuation. Clinical and imaging followup were obtained pre-discharge, 30 days, six months, one year, and annually thereafter to five years. Imaging (CT scans and x-rays) results were evaluated by a central Core Laboratory (M2S, Inc., West Lebanon, NH) to ensure consistency in stent graft integrity, endoleak and migration assessments as well as aneurysm morphology improvements. These results were submitted to the US FDA, with initial approval of the premarket approval application (PMA) in October The complete five-year followup study report was submitted to and approved by the US FDA in Suprarenal Bifurcated Study: This multicenter, prospective, historically controlled clinical study compared 153 standard risk patients with anatomy suitable for endovascular repair to the 66 patients treated with open surgery (described above). Patient enrollment commenced in October 2001, and per the originally approved protocol and patient consent, patients were followed to the primary one year timepoint with continued long-term follow-up commitment. An independent DSMB periodically reviewed the results of this study and recommended study continuation in each review. Clinical and imaging follow-up were obtained pre-discharge, 30 days, six months, one year, and at yearly intervals thereafter. Imaging (CT scans and x-rays) results were evaluated by the central Core Laboratory (M2S, Inc.) to ensure consistency in stent graft integrity, endoleak and migration assessments as well as aneurysm morphology improvements. These results were submitted to the US FDA, with approval of the PMA supplement in October Final five-year follow-up is complete. XL Study: This multicenter, prospective, single arm clinical study enrolled 60 patients with wide infrarenal aortic necks (up to 32mm in diameter) and anatomy suitable for endovascular repair. Enrollment commenced in September 2005, and per the originally approved protocol and patient consent, patients were followed to the primary one-year time point with continued long-term follow-up commitment. An independent DSMB periodically reviewed the results of this study and recommended study continuation in each review. Clinical and imaging follow-up were obtained pre-discharge, 30 days, six months and at yearly intervals. Imaging (CT scans and x-rays) results were evaluated by the central Core Laboratory (M2S, Inc.) to ensure consistency in stent graft integrity, endoleak and migration assessments as well as aneurysm morphology improvements. These results were submitted to the US FDA, with approval of the PMA supplement in November Final five-year follow-up is complete. Please refer to the approved Summary of Safety and Effectiveness Data under P040002: Infrarenal Bifurcated Study (original); Suprarenal Bifurcated Study (S018); XL Aortic Extension Study (S019); Suprarenal Aortic Extension Study (S022); PEVAR Trial (S039). MM1059 Rev 01 8

9 Suprarenal Aortic Extension Study: This multicenter, prospective, single arm clinical study enrolled 44 patients with infrarenal aortic necks up to 26mm in diameter and anatomy suitable for endovascular repair. Enrollment commenced in May 2006, and per the originally approved protocol and patient consent, patients were followed to the primary 30-day time point with continued long-term follow-up commitment. An independent DSMB periodically reviewed the results of this study and recommended study continuation in each review. Clinical and imaging follow-up were obtained pre-discharge, 30 days, six months and at yearly intervals. Imaging (CT scans and x-rays) results were evaluated by the central Core Laboratory (M2S, Inc.) to ensure consistency in stent graft integrity, endoleak and migration assessments as well as aneurysm morphology improvements. These results were submitted to the US FDA, with approval of the PMA supplement in April Final five-year follow-up is complete. PEVAR Trial: This multicenter, prospective, randomized clinical trial enrolled 100 randomized patients (1:1, PEVAR: SEVAR) with anatomy suitable for endovascular repair using the Endologix stent graft system. Randomized trial enrollment commenced in July 2010, and per the originally approved protocol and patient consent, patients were followed to the primary 30-day time point and final 6-month timepoint. An independent DSMB periodically reviewed the results of this study and recommended study continuation. Clinical and imaging follow-up were obtained pre-discharge, 30 days, and at six months. Imaging (CT scan and femoral ultrasound) results were evaluated by an independent assessor and clinical events committee to identify and adjudicate adverse events. These results were submitted to the US FDA, with approval of the PMA supplement in April Final six-month follow-up is complete. Final safety and effectiveness results are included in this section for each study. Patient Status and Accountability As detailed in the approved labeling, Infrarenal and Suprarenal test and control patients were shown to be demographically similar, except that test patients from both studies were significantly older than control patients, and Suprarenal test patients had a significantly increased history of arrhythmia. Patient status and accountability from the time of enrollment through final follow-up are presented in Table 1 (Infrarenal Bifurcated Test Group); Table 2 (Infrarenal Bifurcated Control Groups); Table 3 (Suprarenal Bifurcated Test Group); Table 4 (XL Aortic Extension Test Group); Table 5 (Suprarenal Aortic Extension Test Group) and Table 6 (PEVAR Trial allocated groups). MM1059 Rev 01 9

10 Table 1. Patient and Imaging Accountability Infrarenal Bifurcated Study Test Group 1 Patient Follow-up n (% of eligible) Pts. with Imaging n (% of eligible) Pts. with Adequate Imaging to Assess Parameter -- n (% of eligible) Events Occurring Before Next Visit Interval Eligible Originally Enrolled Clinical Follow-up MM1059 Rev Imaging Follow-up CT Scan Duplex Ultrasound KUB Imaging Implant and <1Mo Events Month (±2 weeks) (98%) 174 (92%) 174 (92%) (68%) Events >1Mo and <6Mo Months (±1 month) (94%) 171 (94%) 171 (94%) (65%) Events >6Mo and <1Yr Year (±2 months) (90%) 156 (90%) 144 (83%) (84%) Events >1Yr and <2Yrs Years (±3 months) (94%) 145 (90%) 145 (90%) (83%) Events >2Yrs and <3Yrs Years (±3 months) (97%) 130 (86%) 130 (86%) (79%) Events >3Yrs and <4Yrs Years (±3 months) (97%) 121 (89%) 121 (89%) (83%) Events >4Yrs and <5Yrs Years (±3 months) (93%) 107 (92%) 107 (92%) (87%) 1 Data analysis sample size variability is due to patient availability for follow-up, as well as, quantity and quality of images available from specific timepoints for analysis. Aneurysm Size 101 (54%) 161 (89%) 156 (90%) 145 (90%) 130 (86%) 121 (89%) 107 (92%) Aneurysm Size Change (89%) 156 (90%) 145 (90%) 130 (86%) 121 (89%) 107 (92%) Endoleak 152 (80%) 147 (82%) 138 (79%) 119 (73%) 103 (68%) 97 (71%) 87 (75%) Migration 163 (86%) 153 (85%) 147 (84%) 133 (82%) 122 (81%) 120 (88%) 104 (90%) Integrity 164 (86%) 162 (90%) 151 (87%) 135 (83%) 119 (79%) 113 (83%) 101 (87%) 2 Of the 192 patients enrolled, four are considered technical failures due to: intraoperative conversion to open repair [n=3]; implant of a non-study device due to access issues [n=1]. Patients continued to return for follow-up. In cases where imaging data at a timepoint were not available, subsequent timepoint imaging data were used. Note: The number of patients who did not withdraw from the study but who missed clinical or imaging visits are: 1Yr (17); 2 Yrs (10); 3 Yrs (4); 4Yrs (4); 5Yrs (4). Table 2. Patient Accountability Infrarenal Bifurcated Study Surgical Control Group Interval Originally Enrolled 66 Patient Follow-up: n (% of eligible) Technical Failure Conversion Death Events Occurring Before Next Visit Eligible Clinical Follow-up Death Withdrawn/Lost Events after surgery but before 1-month visit Month (±2 weeks) (95%) Events >1Mo and <6Mo Month s (±1 month) (92%) Events >6 Months and <1 Yr Year (±2 months) 46 (92%) Events >1Yr and <2 Yrs Years (±3 months) (86%) Events >2Yr and <3 Yrs Years (±3 months) (89%) Events >3Yrs and <4 Yrs Years (±3 months) (97%) Events >4Yr and <5 Yrs Years (±3 months) (96%) Withdrawn/ Lost

11 Table 3. Patient and Imaging Accountability Suprarenal Bifurcated Study Test Group 1 Interval Patient Follow-up n (% of eligible) Eligible Originally Enrolled Events after Implant and <1Mo 1 Month (±2 weeks) Clinical Follow-up (94%) Imaging Follow-up 138 (92%) CT Scan Pts. with Imaging n (% of eligible) (Core Lab) 138 (92%) Duplex Ultrasound 2 (1.3%) KUB Imaging 131 (87%) Pts. with Adequate Imaging to Assess Parameter -- n (%of eligible) Aneurysm Size 136 (91%) Aneurysm Size Change 136 (91%) Endoleak 138 (93%) Migration 134 (89%) Integrity 135 (90%) Events Occurring Before Next Visit Technical Failure Conversion Death Withdrawn/ Events >1Mo and <6Mo Months (±1 month) (82%) 115 (78%) 115 (78%) 3 (2.0%) 124 (90%) 115 (78%) 115 (78%) 115 (78%) 113 (76%) 113 (76%) Events >6Mo and <1Yr Year (±2 months) (92%) 111 (82%) 114 (84%) 4 (2.9%) 121 (89%) 113 (83%) 113 (83%) 114 (84%) 111 (82%) 111 (82%) Events >1Yr and <2Yrs Years (±3 months) (79%) 89 (68%) 89 (68%) 4 (3.1%) 81 (62%) 89 (68%) 89 (68%) 89 (68%) 89 (68%) 89 (68%) Events >2Yrs and <3Yrs Years (±3 months) (71%) 74 (63%) 74 (63%) 7 (5.9%) 57 (48%) 74 (63%) 74 (63%) 74 (63%) 74 (63%) 74 (63%) Events >3Yrs and <4Yrs Years (±3 months) (69%) 54 (52%) 54 (52%) 5 (4.8%) 48 (46%) Events >4Yrs and <5Yrs Years (±3 months) (80%) (63%) (63%) 7 (8.9%) 45 (57%) 1 Data analysis sample size variability is due to patient availability for follow-up and quantity and quality of images available from specific timepoints for evaluation. 54 (52%) (63%) 54 (52%) (63%) 54 (52%) (63%) 54 (52%) (63%) 54 (52%) (63%) 2 Of the 153 patients enrolled, three are considered technical failures due to: intraoperative conversion to open repair [n=1]; implant of a non-study device due to access issues [n=1]; and intraoperative death [n=1]. Two of these patients withdrew at 1Mo. In cases where imaging data at a timepoint were not available, subsequent timepoint imaging data were used. Note: The number of patients who did not withdraw from the study but who missed a visit are: 1Mo (9); 6Mo (24): 1Yr (11); 2 Yrs (27); 3 Yrs (34); 4Yrs (32); 5Yrs (16). Lost MM1059 Rev 01 11

12 Table 4. Patient and Imaging Accountability XL Aortic Extension Study 1 Patient Follow-up n (% of eligible) Pts. with Imaging n (% of eligible) Pts. with Adequate Imaging to Assess Parameter: n (% of eligible) Events Occurring Before Next Visit Interval Eligible Originally Enrolled 2 60 Events after Implant and <1Mo 1 Month (±2 weeks) Clinical Follow-up Imaging Follow-up 59 (98%) CT Scan (Core Lab) 59 (98%) Duplex Ultrasound KUB Imaging (88%) Aneurysm Size 56 (93%) Aneurysm Size Change Endoleak (98%) Migration Integrity Technical Failure Conversion Death Withdrawn/ Events >1Mo and <6Mo Months (±1 month) (95%) 55 (95%) (91%) Events >6Mo and <1Yr Year (±2 months) (93%) (91%) (91%) (84%) Events >1Yr and <2Yrs Years (±3 months) 48 (96%) 48 (96%) 43 (86%) 3 (6.0%) 34 (68%) Events >2Yrs and <3Yrs Years (±3 months) (78%) 31 (76%) 29 (71%) 1 (2.4%) 25 (61%) Events >3Yrs and <4Yrs Years (±3 months) (83%) 30 (83%) 27 (75%) 2 (5.6%) 23 (64%) Events >4Yrs and <5Yrs Years (±3 months) (81%) 24 (92%) 20 (77%) 3 (12%) 14 (54%) 1 Data analysis sample size variability is due to patient availability for follow-up and quantity and quality of images available from specific timepoints for evaluation. 55 (95%) (91%) 43 (86%) 29 (71%) 27 (75%) 20 (77%) 55 (95%) (91%) 43 (86%) 29 (71%) 27 (75%) 20 (77%) In cases where imaging data at a timepoint were not available, subsequent timepoint imaging data were used. 55 (95%) (91%) 43 (86%) 29 (71%) 27 (75%) 20 (77%) 59 (98%) 55 (95%) (91%) 43 (86%) 29 (71%) 27 (75%) 20 (77%) 59 (98%) 54 (93%) (91%) 43 (86%) 29 (71%) 27 (75%) 20 (77%) Note: The number of patients who did not withdraw from the study but who missed specific visits are as follows: 1Yr (4); 2 Yrs (2); 3 Yrs (9); 4Yrs (6); 5Yrs (5). Lost MM1059 Rev 01 12

13 Table 5. Patient and Imaging Accountability Suprarenal Aortic Extension Study 1 Patient Follow-up n (% of eligible) Pts. with Imaging n (% of eligible) Pts. with Adequate Imaging to Assess Parameter: n (% of eligible) Events Occurring Before Next Visit Interval Eligible Originally Enrolled 2 44 Events after Implant and <1Mo Clinical Follow-up Imaging Follow-up CT Scan (Core Lab) Duplex Ultrasound KUB Imaging Aneurysm Size Aneurysm Size Change Endoleak Migration Integrity Technical Failure Conversion Death Withdrawn Month (±2 weeks) (98%) (2%) (86%) (98%) (98%) (98%) (98%) Events >1Mo and <6Mo Months (±1 month) (92%) 36 (92%) 30 (77%) (59%) Events >6Mo and <1Yr Year (±2 months) (91%) 30 (91%) 29 (88%) (67%) Events >1Yr and <2Yrs Years (±3 months) (93%) 26 (93%) 20 (71%) (61%) Events >2Yrs and <3Yrs Years (±3 months) (90%) 18 (90%) 16 (80%) (75%) Events >3Yrs and <4Yrs Years (±3 months) (93%) 13 (93%) 7 (%) (29%) Events >4Yrs and <5Yrs Years (±3 months) (%) (38%) 1 Data analysis sample size variability is due to patient availability for follow-up and quantity and quality of images available from specific timepoints for evaluation. In cases where imaging data at a timepoint were not available, subsequent timepoint imaging data were used. 30 (77%) 24 (73%) 20 (71%) 16 (80%) 7 (%) 4 (%) 30 (77%) 24 (73%) 20 (71%) 16 (80%) 7 (%) 4 (%) 30 (77%) 24 (73%) 20 (71%) 16 (80%) 7 (%) 4 (%) 26 (67%) 29 (88%) 20 (71%) 16 (80%) 7 (%) 4 (%) 26 (67%) 24 (73%) 20 (71%) 16 (80%) 7 (%) 4 (%) / Lost Table 6. Patient and Imaging Accountability PEVAR Trial Allocated Groups Patient Follow-up n (% of eligible) Pts. with Imaging n (% of eligible) Pts. with Adequate Imaging to Assess Parameter: n (% of eligible) Events Occurring Before Next Visit Interval Eligible Clinical Follow-up Imaging Follow-up CT Scan Femoral Ultrasound KUB Imaging Aneurysm Size Aneurysm Size Change PEVAR/ProGlide Group (N= Originally Enrolled) Events after Implant and <1Mo Month (±2 weeks) Events >1Mo and <6Mo Months (±1 month) (98%) Endoleak Migration Integrity Femoral Exposure/Standard EVAR (SEVAR) Group (N= Originally Enrolled) Events after Implant and <1Mo Month (±2 weeks) Events >1Mo and <6Mo Months (±1 month) (98%) 42 (95%) (95%) Technical Failure Conversion Death Withdrawn/ Lost MM1059 Rev 01 13

14 Aneurysm-Related Mortality Aneurysm-related mortality is defined as any death within 30 days of implantation, regardless of cause; and any death after 30 days due to aneurysm rupture, a primary or secondary procedure, or surgical conversion. Table 7 summarizes the aneurysm-related deaths in the Infrarenal Bifurcated Test, Surgical Control, Suprarenal Bifurcated Test, XL Study, Suprarenal Aortic Extension, and PEVAR Trial groups. Table 7. Aneurysm-Related Death Summaries By Study Group Days Post-Op Infrarenal Test Group Patient Age Patient Gender 1 83 M Cardiac arrest Summary 9 80 F Myocardial infarction after attempted thoracic repair with Talent endograft M Ischemic heart disease F Death during conversion to open repair after iliac artery rupture during attempted secondary endovascular intervention for proximal Type I endoleak. Suprarenal Test Group 0 82 M Cardiopulmonary arrest secondary to iliac artery rupture/hemorrhage 3 83 M Macroembolization involving the bowel and intraabdominal organs M Multi-organ failure Surgical Control Group 3 69 M Metabolic acidosis 9 79 F Pulmonary embolism F Cardiopulmonary arrest F Acute respiratory distress syndrome XL Study Group None Suprarenal Aortic Extension Group None MM1059 Rev 01 14

15 Figure 1 presents the Kaplan-Meier analysis of aneurysm-related mortality in the Infrarenal Bifurcated Test Group, Suprarenal Bifurcated Test Group, and the Surgical Control Group. Figure 1. Freedom from Aneurysm-Related Mortality to 5 Years, Infrarenal Bifurcated Test, Suprarenal Bifurcated Test, and Surgical Control Groups Powerlink Infrarenal Powerlink Suprarenal Surgical Control Timepoint No. at Risk Survival No. at Risk Survival No. at Risk Survival 1 Month Months Year Years Years Years Years MM1059 Rev 01 15

16 All-Cause Mortality Figure 2 presents the Kaplan-Meier analysis of all-cause mortality in the Infrarenal Bifurcated Test, Suprarenal Bifurcated Test Group, and the Surgical Control Group. Figure 2. Freedom from All-Cause Mortality to 5 Years, Infrarenal Bifurcated, Suprarenal Bifurcated, and SurgicalControl Groups Powerlink Infrarenal Powerlink Suprarenal Surgical Control Timepoint No. at Risk Survival No. at Risk Survival No. at Risk Survival 1 Month Months Year Years Years Years Years MM1059 Rev 01 16

17 A summary of the deaths reported to date in each study test group and in the surgical control group is provided in Table 8, organized by probable body system. If the death occurred within 30 days, or otherwise was found to be aneurysm-related, it is listed as such. These deaths were previously detailed in Table 5. Among the study groups, the largest causative categories are cancer-related, cardiac related, and pulmonary-related. Table 8 Summary of All-Cause Deaths to 5 Years Listed by Probable Body System Relatedness Category/Body System Relatedness Infrarenal Bifurcated [N=192] Suprarenal Bifurcated [N=153] Surgical Control [N=66]* XL Aortic Extension [N=60] Suprarenal Aortic Extension [N=44] PEVAR Randomized Trial [N=151] n (%) n (%) n (%) n (%) n (%) n (%) Aneurysm-Related 4 (2.1%) 3 (2.0%) 4 (6.1%) (0.7%) Cancer-Related 14 (7.3%) 5 (3.3%) 5 (7.6%) 6 (10%) 1 (2.3%) 2 (1.4%) Cardiac-Related 8 (4.2%) 11 (7.1%) 3 (4.5%) 3 (5.0%) 0 1 (0.7%) Cerebrovascular-Related 3 (1.6%) 2 (1.3%) 1 (1.5%) 2 (3.3%) 2 (4.6%) 0 Gastrointestinal-Related 1 (0.5%) (2.3%) 0 Pulmonary-Related 8 (4.2%) 8 (5.2%) 2 (3.0%) 3 (5.0%) 4 (9.1%) 0 Other 4 (2.1%) 4 (2.6%) 2 (3.0%) 4 (6.7%) 1 (2.3%) 0 Other includes: Liver cirrhosis, multiorgan failure, kidney failure, sepsis, and natural causes (Infrarenal Bifurcated Test group); sepsis; asphyxial suicide, unknown, and natural causes (Suprarenal Bifurcated Test group); multiorgan failure; unknown (Control group); dementia and malnutrition, multiorgan failure, pneumonia, thrombocytopenia (XL group); accidental fall (Suprarenal extension group). *Deaths reported to Endologix that occurred after the final protocol-specified follow-up are included (cancer [1]; cardiac [1]). Major Adverse Events The protocol-specified primary safety endpoint in the Infrarenal and Suprarenal Bifurcated studies is the proportion of patients with a major adverse event (MAE) within one year compared to the surgical control group. Through one year, patients treated with the Endologix stent graft in both studies experienced fewer MAEs compared with control patients treated with open surgery. In each study, hypothesis testing of the study results met the one-year safety endpoint success criterion. MAEs reported from the time of enrollment through one year (0 Days-1 Year), and after one year through current follow-up to five years (>1 Year-5 Years) are presented in Table 9. Within one year, fewer study patients experienced an MAE compared with patients treated with open surgery. Longer term follow-up of patients in the test group included clinical visits as well as Core Laboratory evaluated diagnostic imaging results (CT scans and x-rays). Longer term follow-up in control group patients who remained in the study included primarily telephone follow-up. Notably, no aneurysm rupture was observed throughout five-year follow-up in any study. Further details on secondary procedures are provided in the Treatment Effectiveness subpart of this Section. Additional details on explants are provided in Section 3. MAE in these studies is a composite endpoint consisting of: all-cause death; aneurysm rupture; conversion to open repair; myocardial infarction; coronary intervention; renal failure; respiratory failure; secondary intervention; and stroke. MM1059 Rev 01 17

18 Table 9. MAEs, Infrarenal Bifurcated and Suprarenal Bifurcated Test vs. Control 1 Parameter Infra Test n (%) 0 Days-1 Year 2 >1 Year-5 Years 2 Supra Test n (%) Control n (%) Infra Test n (%) Supra Test n (%) Number of Patients Control n (%) Patients with 1 MAE 46 (24%) 32 (21%) 22 (33%) 64 (37%) 54 (41%) 8 (17%) All-Cause Mortality 3 13 (6.8%) 12 (7.8%) 9 (14%) 30 (17%) 22 (17%) 6 (13%) AAA Rupture Conversion/Explant 4 (2.1%) 2 (1.3%) (3.1%) --- Coronary Intervention 3 (1.6%) 5 (3.3%) 0 22 (13%) 8 (6.1%) 2 (4.2%) Myocardial Infarction 7 (3.7%) 1 (0.7%) 6 (9.1%) 11 (6.5%) 5 (3.8%) 1 (2.1%) Renal Failure 6 (3.1%) 3 (2.0%) 7 (11%) 1 (0.6%) 3 (2.3%) 0 Respiratory Failure 4 (2.1%) 4 (2.6%) 5 (7.6%) 2 (1.2%) 2 (1.5%) 0 Secondary Procedure 20 (10%) 12 (8.8%) 2 (3.0%) 11 (6.5%) 20 (15%) 0 Stroke 5 (2.6%) 2 (1.3%) 2 (3.0%) 10 (5.8%) 1 (0.8%) 0 1 Enrolled patients: Infrarenal Bifurcated Test: N=192; Suprarenal Bifurcated Test: N=153; Control: N=66. Results (n) shown as number of patients with at least one event (% of patients available in group). Some patients may experience more than one event. 2 The events in the grouping 0 Days-1 Year includes all events occurring up to 14 months post-procedurally. The events in the grouping >1 Year-5 Years include all events after 14 months and up to 62 months post-procedurally. 3 All deaths within 30 days are considered AAA and procedure related. Of the late Powerlink deaths, one occurring at approximately one year was considered AAA and procedure related. MM1059 Rev 01 18

19 Figure 3 presents the Kaplan-Meier analysis of major adverse events in the Infrarenal Bifurcated Test, Suprarenal Bifurcated Test Group, and the Open Surgical Control Group. Figure 3. Freedom from Major Adverse Events to 5 Years, Infrarenal Bifurcated, Suprarenal Bifurcated, and SurgicalControl Groups Powerlink Infrarenal Powerlink Suprarenal Surgical Control Timepoint No. at Risk Survival No. at Risk Survival No. at Risk Survival 1 Month Months Year Years Years Years Years MM1059 Rev 01 19

20 MAEs reported in the XL and Suprarenal Aortic Extension studies through one year are itemized in Table 10. Results are consistent with the Infrarenal and Suprarenal Bifurcated studies, and with the natural progression of this elderly patient population. Notably, no aneurysm rupture was observed in follow-up. One conversion to open repair was performed in one XL patient in conjunction with a total open repair of a thoracic aortic aneurysm. Further details on secondary procedures are provided in the Treatment Effectiveness subpart of this Section. Table 10. MAEs, XL and Suprarenal Aortic Extension Test Groups 1 Parameter XL Test n (%) 0-30 Days 2 0 Days-1 Year 2 >1 Year to 5 Years 2 Supra Ext. Test n (%) XL Test n (%) Supra Ext. Test n (%) XL Test n (%) Number of patients Supra Ext. Test n (%) Patients with 1 MAE 1 (1.7%) 1 (2.3%) 10 (17%) 9 (20%) 22 (44%) 9(32%) All-Cause Death (8.3%) 4 (9.1%) 13 (26%) 5 (18%) AAA Rupture Conversion/Explant (2.0%) 0 Coronary Intervention (8.0%) 1 (3.6%) Myocardial Infarction (1.7%) 1 (2.3%) 3 (6.0%) 0 Renal Failure 0 1 (2.3%) 3 (5.0%) 2 (4.5%) 3 (6.0%) 2 (7.2%) Respiratory Failure 1 (1.7%) 1 (2.3%) 2 (3.3%) 2 (4.5%) 3 (6.0%) 1 (3.6%) Secondary Procedure (1.7%) 5 (11%) 4 (8.0%) 2 (7.2%) Stroke (5.0%) 0 2 (4.0%) 0 1 XL: N=60; Suprarenal Aortic Extension: N=44. Results (n) shown as number of patients with at least one event (% of patients available in group). Some patients may experience more than one event. 2 The events in the grouping 0-30 days include all events procedurally and up to and including exactly 30 days post-procedurally. The events in the grouping 0 Days-1 Year include all events procedurally and up to 365 days post-procedurally. 3 Of the late deaths (>30 days), none was considered AAA or procedure related. MM1059 Rev 01 20

21 In the PEVAR Trial, procedural technical success among the study groups was 94% (PEVAR/ProGlide) and 98% (SEVAR). MAEs and vascular complications reported in the PEVAR Trial are itemized in Table 11. Across groups, a low rate of events was observed. Table 11. MAEs and Vascular Complications, PEVAR Trial Randomized Groups 1 Parameter PEVAR/PG n (%) 0-30 Days 2 31 Days-6 Months 2 SEVAR/FE n (%) Major Adverse Events PEVAR/PG n (%) SEVAR/FE n (%) Number of patients Patients with 1 MAE 2 (4.0%) 5 (10%) 1 (2.1%) 3 (7.0%) All-Cause Death (2.3%) AAA Rupture Conversion/Explant Bowel Ischemia Cardiac Morbidity Neurological Complication 0 3 (6.0%) 0 0 Renal Failure 2 (4.0%) 1 (2.0%) 1 (2.1%) 0 Respiratory Failure 1 (2.0%) 1 (2.0%) 0 0 Secondary Procedure 0 2 (4.0%) 0 2 (4.6%) Vascular Complications Patients with 1 Event 4 (8.0%) 8 (16%) 2 (4.2%) 1 (2.3% Arteriovenous Fistula Femoral Neuropathy 0 1 (2.0%) 0 0 Hematoma Hemorrhage 1 (2.0%) 3 (6.0%) 0 0 Infection Lymphocele 0 1 (2.0%) 0 1 (2.3%) Distal Thrombosis/Stenosis 2 (4.0%) 3 (6.0%) 0 0 Vascular Injury 1 (2.0%) 1 (2.0%) 2 (4.2%) 0 1 PEVAR/PG (ProGlide): N=; SEVAR/FE (femoral exposure): N=. Results (n) shown as number of patients with at least one event (% of patients available in group). Some patients may have experienced more than one event. 2 The events in the grouping 0-30 days include all events procedurally and up to 30 days post-procedurally. The events in the grouping 31 Days-6 Months include all events from day 31 to 183 post-procedurally. 3 Of the late deaths (>30 days), none were considered AAA or procedure related. Procedural technical success is defined as successful vascular access per randomized assignment and without conversion to femoral exposure in percutaneous groups, and successful endovascular device delivery and deployment using the study device. MM1059 Rev 01 21

22 Treatment Effectiveness Aneurysm Sac Exclusion. The Core Laboratory assessed CT scans to determine the effectiveness of aneurysm sac exclusion, as measured by maximum diameter changes over time. Consistent with the literature, aneurysm sac diameter decrease or increase was defined as a change of >5mm compared to baseline. 1 A summary of the results to five years is presented in Table 12 and Table 13. No aneurysm rupture has occurred in any patient. At five years, the large majority of patients in each study were observed with stable or decreased aneurysm sac diameter. These long-term data are consistent in demonstrating effective aneurysm sac exclusion. Since the eptfe grafts used in all of the clinical studies are identical in size, design, and processing, a similar rate of sac increase was anticipated in the absence of other variables. Slightly higher rates of increased aneurysm sac diameter reported in the Suprarenal Bifurcated, XL, and Suprarenal Aortic Extension studies compared to the Infrarenal Bifurcated study. These higher rates were attributed to Type II endoleaks in the majority of patients (Type I endoleak was causal in six patients). Core laboratory comparison of the Type II endoleak rates among the Infrarenal Bifurcated and Suprarenal Bifurcated studies demonstrates a substantial disparity in the prevalence of Type II endoleaks (23% Suprarenal vs. 15% Infrarenal) categorized as moderate to severe due to a patent IMA or multiple lumbar arteries (60% Suprarenal vs. 42% Infrarenal). As reported in the literature, the incidence of Type II endoleak varies in the endovascularly-treated population from 8% to 32%. 2 It is therefore plausible that the difference in aneurysm sac enlargement in the XL and Suprarenal Aortic Extension clinical studies is also due to differences in the prevalence and severity of Type II endoleak due to large patent IMA or lumbar arteries. Table 12. Aneurysm Sac Diameter Change Over Time, Infrarenal and Suprarenal Bifurcated Studies Change* 1 Year % (n/n) Infrarenal Bifurcated Test Group 2 Years % (n/n) 3 Years % (n/n) 4 Years % (n/n) 5 Years % (n/n) No Growth 99% (154/156) 97% (141/145) 96% (125/130) 96% (116/121) 92% (98/107) Decreased 37% (57/156) 54% (78/145) 60% (78/130) 66% (80/121) 71% (76/107) Stable 62% (97/156) 43% (63/145) 36% (47/130) 30% (36/121) 21% (22/107) Increased 1.3% (2/156) 2.8% (4/145) 3.8% (5/130) 4.1% (5/121) 8.4% (9/107) Suprarenal Bifurcated Test Group No Growth 91% (106/117) 91% (77/85) 86% (64/74) 89% (48/54) 86% (43/) Decreased 52% (61/117) 38% (32/85) 49% (36/74) 59% (32/54) % (25/) Stable 38% (45/117) 53% (45/85) 38% (28/74) 30% (16/54) 36% (18/) Increased 9.4% (11/117) 9% (8/85) 14% (10/74) 11% (6/54) 14% (7/) Includes evaluable CTs received and reviewed by the Core Lab. *No Growth: Decreased + Stable; Decreased: >5mm reduction; Stable: 5mm or less change; Increased: >5mm increase. Among patients identified with a sac diameter increase, all but one was attributed to Type II endoleak. This one patient (Suprarenal Bifurcated Study, 1-Year follow-up) was identified with both a Type I and Type II endoleak. 1 Chaikof EL. Capturing an accurate measure of success-outcomes and endpoints in endovascular aneurysm repair. J Vasc Surg 2002;36: Heikkinen MA, Arko FR, and Zarins CK. What is the significance of endoleaks and endotension? Surg Clin N Am 2004;84: MM1059 Rev 01 22

23 Table 13. Aneurysm Sac Diameter Change Over Time, XL and Suprarenal Aortic Extension Studies Change* XL Aortic Extension Test Group 1 Year % (n/n) 2 Years % (n/n) 3 Years % (n/n) 4 Years % (n/n) 5 Years % (n/n) No Growth 98% (/51) 93% (42/45) 80% (24/30) 91% (20/22) 92% (11/12) Decreased 27% (14/51) 51% (23/45) 57% (17/30) 77% (17/22) 67% (8/12) Stable 71% (36/51) 44% (19/45) 23% (7/30) 14% (3/22) 25% (3/12) Increased 2.0% (1/51) 7.0% (3/45) 20% (6/30) 9.1% (2/22) 8.3% (1/12) Suprarenal Aortic Extension Test Group No Growth 88% (21/24) 100% (20/20) 88% (14/16) 86% (6/7) 100% (4/4) Decreased 38% (9/24) 45% (9/20) % (8/16) 43% (3/7) 75% (3/4) Stable % (12/24) 55% (11/20) 38% (6/16) 43% (3/7) 25% (1/4) Increased 12% (3/24) 0 12% (2/16) 14% (1/7) 0 Includes evaluable CTs received and reviewed by the Core Lab. *No Growth: Decreased + Stable; Decreased: >5mm reduction; Stable: 5mm or less change; Increased: >5mm increase. Among patients identified with a sac diameter increase, the majority were attributed to Type II endoleak. The exceptions in each study are as follows: XL Aortic Extension Study: 2 patients at the 2-year and 3-year follow-up were observed with a Type I and Type II endoleak. Suprarenal Aortic Extension Study: 2 patients at the 1-year follow-up and 1 patient at the 3-year follow-up were observed with a Type I endoleak. Migration. The Core Laboratory assessed CT scans to determine distal device movement relevant to the initial implant location (baseline CT scan) at each follow-up. Consistent with the literature, migration is defined as device movement of >10mm relative to the original implant location. In the Infrarenal Bifurcated study, a total of eight patients (4.2%) were observed with distal migration over five years; secondary proximal extension placement was performed in two patients (no endoleak). In the Suprarenal Bifurcated study, a total of three patients (2.0%) have been observed with distal migration; only one required proximal extension placement. Among the XL and Suprarenal Aortic Extension studies, one patient with a rapidly enlarging thoracic aortic aneurysm was identified with neck dilation and migration, and underwent a total open repair of the thoracic and abdominal aorta at 22 months. No migration of an anatomically-fixed bifurcated stent graft was observed. MM1059 Rev 01 23