RISULTATI A DISTANZA DELL ENDOPROTESI OVATION
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1 RISULTATI A DISTANZA DELL ENDOPROTESI OVATION SONIA RONCHEY MD PhD SAN FILIPPO NERI - ROMA MM1312 Rev Endologix, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
2 Ovation OVATION OVATION PRIME OVATION ix OVATION ALTO / ?2018 >10000 patients treated with the Ovation platform Expanding global reach to patients with straight-forward to challenging anatomy with an easy to use system Confidential. For Internal Use Only. MM1263 Rev. 01 2
3 Ultra low profile path to durability with a patient-specific seal VALIDATION THROUGH CLINICAL EVIDENCE IN 1,500+ PATIENTS 161 patients 501 patients 250 patients 285 patients 375 patients 36 Centers US, Chile, Germany 5 Year Results 30 Centers 3 Year Results FAST Track EVAR 40 Centers 30d Results US 39 Centers EU 12 Centers Enrolling Alto IDE and PMR Enrollment starting in 2017 The Ovation Alto is not approved in any market; Ovation Alto is an investigational device in the United States, limited by federal (or United States) law to investigational use only.
4 Ovation Global Pivotal Trial 161 patients enrolled in Chile, Germany and USA from Nov 2009 Dec 2011 First Global Pivotal Trial Broadest Indication Statement First-in-Human / No roll-in at All Sites United States Chile Germany Botti, Charles Cheema, Mohiuddin Clair, Daniel Eidt, John Eskandari, Mark Glickman, Mark Gray, Bruce Haser, Paul Hassoun, Heitham Henretta, John Hodgson, Kim Jain, Ash Jicha, Douglas Jones, Paul Riverside Methodist Hospital Hartford Hospital Cleveland Clinic Central Arkansas VA Northwestern Memorial Sentara Medical Group Greenville Hospital UMDNJ Methodist Hospital Mission Hospital Southern Illinois University Washington Hospital Santa Rosa Memorial Mercy Medical Center Jordan, William UAB Kasirajan, Karthik Emory University Krajcer, Zvonimir St. Luke s Hospital Laird, John UC Davis Maini, Brijeshwar Moffitt Heart and Vascular Makaroun, Michel UPMC Maldonado, Thomas NYU Hospital Mehta, Manish Albany Medical Center Mishkel, Gregory Prairie Heart Moore, Wesley UCLA Motew, Stephen Forsyth Medical Center Murkherjee, Dipankar Inova Fairfax Hospital Rizvi, Adnan Minneapolis Heart Institute Sternberg, Charles Ochsner Health System Valdes, Francisco Catholic University Brunkwall, Jan Krankenberg, Hans Mathias, Klaus Nolte, Thomas Scheinert, Dierk Sievert, Horst Torsello, Giovanni Uni. Klinik Ko ln Medizinisches Versorgungszentrum, HH Klinikum Dortmund Herz und Gefa ßzentrum, Bad Bevensen Park Krankenhaus, Leipzig CVC, Frankfurt St. Franziskus-Hospital, Münster
5 Anatomical Characteristics 69% of patients had one or more hostile neck anatomies; 31% had small access vessels Number of Hostile Neck Characteristics per patient Hostile Neck Characteristics N=161 Neck angle % (5) Neck Length <10mm 16.1% (25) Two, Three; None; 31% Neck Diameter 28mm 5.6% (9) Reverse Taper 26.7% (43) 50% Circumferential Calcium/Thrombus 2mm 62.1% (100) Access Vessel Characteristics Minimum Access Vessel <6mm 31% (50) Ovation Pivotal Trial data as of August 2, 2016 One; 36%
6 Adjunctive Devices for Proximal Seal LIFE Registry Ovation ix Adjunctive Proximal Device 3.2% CASE EXAMPLE Palmaz stent used to address intraoperative Type1a endoleak due to undersized graft. 3 year follow-up shows no neck dilatation. Palmaz stent and sealing ring maintain wall apposition.
7 Type Ia Endoleak Intervention through 5 Years 97% Five Year Freedom from Reintervention for Type 1a Endoleak Ovation Pivotal Trial data as of August 2, 2016
8 Type II Endoleak Reintervention through 5 Years for Type II Endoleak in line with EVAR Type II Endoleak Ovation Pivotal Trial - Global Ovation Pivotal Trial - US Endurant IDE Zenith IDE Excluder IDE Core Lab at 5 Yr 28.8% 23% 7.2% 4.3% 12.3% Reintervention 5 Yr 9.9% 8.1% 6.7% 11.0% 7.1% Ovation Trial recommended smaller (0.6mm-2.0mm) CT slices (vs. 3-5mm slices in other EVAR trials); Median core-lab adjudicated type II endoleak volume at 1 year was 1 ml; For comparison, mean volume of type II endoleaks that undergo intervention is 7 ml; Those that require no intervention average 4 ml Mehta et al. J Vasc Surg 2014;59:65-73 Keedy et al. AJR 2011;197: Ovation Pivotal Trial data as of August 2, 2016
9 Freedom from Reintervention through 5 Years 97% for type I endoleak 96% for occlusion 90% for type II endoleak 84% for all reintervention US Cohort - Pivotal Trial Ovation Pivotal Trial data as of August 2, 2016
10 Freedom from Mortality through 5 Years 98% Five Year Freedom from ARM 75% Five Year Freedom from ACM Ovation Pivotal Trial data as of August 2, 2016
11 Risk of Aortic Neck Dilatation with EVAR SELF EXPANDING STENT GRAFT Chronic outward force from stent, combined with blood pressure, can result in aortic neck dilatation. 24.6% Neck Dilation over a 15 month to 9 year period Increased size of aorta 26% incidence of clinical events with dilation Type Ia endoleak, migration, and reintervention vs 2% Without dilation
12 Aortic Neck Dilatation with Ovation STABLE NECK DIAMETER THROUGH 5 YEARS Ovation Pivotal Trial data as of August 2, Monahan JVS 2010: 52: N=46. Devices: Cook Zenith 2 Rodway EJVES 2008;35: EVAR: N=67, Open N=56. Data to 2 3 Core Lab evaluation, Ovation Global Pivotal Trial. N=94. Data as of Aug years. 2, Neck dilation = growth > 3mm at 10mm, 13mm, and 15mm below renals
13 J Vasc Surg Jan;63(1): patients Median 32 months (range 24-50) Zone B & C - No Neck enlargement ( 2mm) - No Stent graft migration( 3mm) Conclusion Non-expansive circumferential wall apposition of sealing ring creates no chronic outward radial force No aortic neck dilatation is expected. MM1389 Rev01 At 2y follow-up the mean change in 13 diameters was -0,06 ± 0.97 mm (SE
14 Adverse Events Lowest Reported MAE Rate Across US Pivotal Trial Cohorts for FDA-Approved AAA Devices Ovation Pivotal Trial Patients Enrolled 161 / 111 US 150 Endurant IDE Zenith IDE Excluder IDE 200 / 100 Std Risk / High Risk ASA Class III /IV 60% / 7% 49% / 0% NR NR Major Adverse Event 0-30d / d 2.5% / 3.8% 4.0% / 6.5% NR 5.7% / 5.1% Freedom from Conversion 100% 100% 98% / 98% 97% Freedom from Rupture 99% 99% 100% / 99% 99% Freedom from AAA-Related Mortality (5 Yr) 98% 99% 99% / 94% 98% 565 Freedom from All Cause Mortality (5 Yr) 75% 83% 83% / 58% 70% Results for EVAR commercially available devices shown per the respective US FDA Summary of Safety and Effectiveness Data (SSED) and Annual Clinical Reports. Ovation Pivotal Trial data as of August 2, 2016
15 OVATION EUROPEAN POST MARKET REGISTRY REAL WORLD PERFORMANCE Multicenter, prospective 501 patients, 30 EU sites Patients enrolled May 2011 Dec 2013 Ovation Prime and Ovation ix 3-Year Results Presented at LINC 2017
16 1/3 OF PATIENTS HAD COMPLEX MORPHOLOGY Severe Neck Calcification; 3,0% Neck Length <10mm; 5,3% Neck Angle 60 ; 4,3% Severe Neck Thrombus; 5,5% Min EIA Dia <7mm; 41,6% Neck Dia 28mm; 12,8% Storck et al JCVS 2016 Gender Differences in Ovation EU PMR
17 Procedural Outcomes In the Ovation study, subjects undergoing percutaneous access achieved similar clinical outcomes with low time spent related to anesthesia, procedure and fluoroscopy. 39% N=501 Percutaneous Technical Success (successful deployment of 99.8% device) 59% Cutdown 3% Percutaneous and Cutdown Polymer leak with anaphylactic shock 0.2% Anesthesia Time (mean) Procedure Time (mean) Fluoroscopy Time (mean) 150 minutes 51 minutes 22.2 minutes Ovation EU PMR data as of October 6, 2016
18 DURABLE RESULTS THROUGH 3 YEARS 99% Freedom from Rupture 99% Freedom from Conversion One contained rupture, day 30, from Type Ib endoleak. Treated with hypogastric occlusion and iliac limb extension. Three conversions: day 88 due to aortic occlusion, day 449 due to Type I/II endoleak, and 477 due to aorto-enteric fistula Ovation EU PMR data as of October 6, 2016
19 DURABLE RESULTS THROUGH 3 YEARS 97% Freedom from Type I Endoleak 99% Freedom from Type III Endoleak Ovation EU PMR data as of October 6, 2016
20 FREEDOM FROM 3 YEAR REINTERVENTION 97% for Type I Endoleak 95% for Type II Endoleak 97% for Occlusion Ovation EU PMR data as of October 6, 2016
21 FREEDOM FROM 3 YEAR MORTALITY 99% Freedom from AAA-Related Mortality 88% Freedom from All Cause Mortality Ovation EU PMR data as of October 6, 2016
22 POST MARKET REGISTRIES: OVATION vs. ENDURANT Ovation EU PMR Medtronic ENGAGE Patients Enrolled ASA Class III/IV 48.5% 52.1% AAA-Related Mortality 0.4% 1.5% All Cause Mortality 12.8% 19.8% Rupture 0.2% 0.5% Conversion 0.8% 0.9% Type I/III Endoleak at 3 years 0.9% 1.5% Type I/III Endoleak through 3 years 3.2% nr Reintervention for Type I/III Endoleak 3.6% 3.0% Reintervention for Type II Endoleak 4.6% nr Occlusion 2.0% 3.9% Ovation data are site reported. Three year ENGAGE results excerpted from ENGAGE 4-Year Results Presentation, Sambeek et al. VEITH Symposium, November 2015 Ovation EU PMR data as of October 6, 2016
23 WOMEN WITH AAA: AN UNDERSERVED POPULATION More women than men are ineligible for EVAR Inadequate neck length Narrow access vessels Women are underrepresented Enrollment of women in cardiovascular clinical trials is disproportionately low Outcomes in women are worse - Arterial injuries, longer LOS, higher readmission rates, greater mortality 1 Morrison T, Fillinger M, Meyer C, et al. Gender disparities in endovascular treatment options for infrarenal abdominal aortic aneurysms. Published June 25, 2013.
24 GENDER SUB-ANALYSIS: 432 MEN, 69 WOMEN Male Female 70% 65% 60% 50% 40% 38% 30% 20% 10% 0% Min EIA Dia <7mm 17% 12% Neck Dia 28mm 10% 12% 4% 4% 3% 6% 2% 5% Neck Angle 60 Neck Length <10mm Severe Neck Calcification Severe Neck Thrombus Ovation EU PMR data as of October 6, 2016
25 WOMEN AND MEN DERIVED SIMILAR OUTCOMES Three Year Outcomes Men Women N=432 N=69 P-Value Freedom from AAA mortality 99% 100% 0.57 Freedom from All-Cause Mortality 87% 90% 0.77 Freedom from Type I Endoleak 97% 94% Freedom from Type III Endoleak 99% 100% 0.42 Freedom from Occlusion 99% 94% Freedom from Conversion 99% 99% 0.32 Freedom from Rupture 99% 100% 0.69 Freedom from Aneurysm Enlargement 5mm 93% 91% 0.59 Ovation EU PMR data as of October 6, 2016
26 AAA-RELATED REINTERVENTION Reason for Reintervention Men N=432 Women N=69 P-Value Type Ia 2.1% (9) 4.3% (3) 0.08 Type Ib 1.2% (5) 1.4% (1) 0.10 Type II 4.2% (18) 13% (9) 0.08 Type III 0.5% (2) -- na Occlusion 2.5% (11) 4.3% (3) 0.03 Stenosis 0.9% (4) 1.4% (1) 0.18 Limb Migration 0.7% (3) 1.4% (1) 0.32 Infection (AEF) 0.2% (1) -- na Ovation EU PMR data as of October 6, 2016
27 FREEDOM FROM MORTALITY THROUGH 3 YEARS Freedom from ARM 99% Men 100% Women Freedom from ACM 87% Men 90% Women P= P= Ovation EU PMR data as of October 6, 2016
28 FREEDOM FROM ENDOLEAK AND OCCLUSION THROUGH 3 YEARS Freedom from Type I Endoleak 97% Men 94% Women Freedom from Type III Endoleak 99% Men 100% Women Freedom from Occlusion 98% Men 94% Women P= P= P= P= Ovation EU PMR data as of October 6, 2016
29 FREEDOM FROM RUPTURE AND CONVERSION THROUGH 3 YEARS Freedom from Rupture 99.7% Men 100% Women Freedom from Conversion 98.5% Men 99.5% Women P= P= Ovation EU PMR data as of October 6, 2016
30 FREEDOM FROM SAC GROWTH THROUGH 3 YEARS Freedom from AAA Growth >5mm 93% Men 91% Women P= Ovation EU PMR data as of October 6, 2016
31 Clinical Evidence to Validate the Ovation Platform Over 10,000 patients worldwide have been treated with the Ovation Platform, with over 1,500 subjects in a tightly controlled study or registry Patient demographics, anatomical characteristics, and procedural characteristics indicate a challenging patient cohort. Short-term results show lower major adverse events, faster discharge, and fewer readmissions compared to traditional EVAR Mid-term results show low rupture and conversion rates, low Type I / III endoleaks, and stable aortic neck diameter Women and men derive similar benefits with Ovation through 3 years These data provide compelling evidence that the Ovation system can expand EVAR access to more patients and improve EVAR outcomes for all patients
32 MM1389 Rev01 32
33 MM1389 Rev01 33
34 MM1389 Rev01 34
35 MM1389 Rev01 35
36 27MAY34-BC 07SEP35-VA 28AUG30-PR 22SEP38-RA 14MAR40-MP 06FEB38-CS 21FEB56-MF 28MAY35-GR Personal Experience
37 Patients 112 Personal experience Gender (Male/Female) 99/11 Mean Age (years) (Range) Proximal neck diameter Proximal neck lenght Aneurysm Iliac (R/L) Access vessels (R/L) 74,6 (55-91) 24.6 ( ) 15.6 (4.3-30) 50.8 ( ) 13.7/13.6 ( / ) 7.4/7.1 ( / ) Delta aorta - aneurysm 60% (40-65%) Device Time (min) 45 (25-70)
38 Personal experience: 112 PTS Personal experience OVATION 26 OVATION PRIME 69 OVATIONiX 17
39 Personal experience: 112 PTS Aortic Neck 65% 55% 39% 28% 10% Neither Criteria 1% Dirty Angled Flared Tapered Short 39
40 Personal experience: 112 PTS Iliacs Arteries 68% 35% 32% 20%
41 100% percutaneous 97% under local anesthesia
42 ULTRA LOW PROFILE PATH.. TO SAFETY, FASTER DISCHARGE, AND FEWER READMISSIONS 30-day results Ovation LIFE EVAR Traditional EVAR Percutaneous Access No General Anesthesia No ICU Admission Next-day Discharge Procedure Time MAE 0.5% 3-4% 2 min ICU days LOS days day Readmission 1.6% 8% 1. 30d MAE rates for commercially available EVAR devices per US FDA SSED reports and post market global registries. Data on file. 2. Premier EVAR. 3. Chen SL et al. Perioperative Risk Factors for Readmission Following EVAR. Presented at SCVS, Gupta PK, et al. Unplanned readmissions after vascular surgery. J Vasc Surg 2014;59: LIFE data as of August 2, ,4
43 Narrow/Tortuous Access vassels Thrombus at sealing zone Male years Neck Diameter 18.9mm Calcification at Bifurcation (10x13 mm) Tortuosity Aneurysm Diameter Iliac Diameters Access Diameters 45.9mm R: 9.6mm L: 10.0mm R: 4.9 mm L: 5.1 mm Access
44 Difficult Access - Result Pre Procedure Post Procedure 12 Month Follow-up
45 Absence of nitinol skeleton implies even: - Risk of limb collapse in case of tight luminal space - Risk of kinking in angulation - Risk of limb occlusion
46 Small/Diseased iliac arteries : previous stenting on the left side 46
47 Pre Procedure Post Procedure After 5 days 47
48 Pre 5 days after. R-Branch occlusion Recanalization & STENTING Intra Post LESSON LEARNED BALLOONING &/OR STENT RELINING TO BE DONE IMMEDIATELY!! 48
49 Personal experience: 112 pts Immediate results Immediate complications Bleeding 1 Polimer extravasation 1 (allergic reaction no sequaele) Endoleak type I 3 * (2 TREATED 1 SELF SEALED) Branch occlusion 1 * (TREATED) OVATION
50 Personal experience: 112 pts late results Mean f-up 42,8 (0-84 mths) Death 11 TYPE A DISSECTION 1 Type I EL 1* Type II EL 35* Branch occlusion 1 ** * TREATED (CHIMNEY + CUFF) ** TREATED * 40% in case of diseased iliac
51 CONCLUSIONS Ovation safely and effectively addresses previously unmet clinical needs Good immediate resuts Good mean and long term results
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