Durability of The Endurant Stent-Graft through 5 Years

Transcription

1 Durability of The Endurant Stent-Graft through 5 Years Michel S. Makaroun MD Co-Director, UPMC Heart and Vascular Institute Professor and Chair, Division of Vascular Surgery University of Pittsburgh School of Medicine

2 Endurant Characteristics M-shaped proximal stent for improved neck conformability Limbs stent geometry and spacing designed for flexibility One-piece, laser-cut, nitinol suprarenal stent with anchoring pins

3 Endurant Sizes Main Body Iliac Limbs Graft Size Vessel treated Profile 18 or or 16

4 Endurant Delivery System Slow Deliberate and Accurate Proximal Deployment Relatively Low Profile/ Trackable /Hydrophilic Coating Controlled release of the suprarenal anchoring pins

5 Endurant Multiple Options for Patient Customization Endurant II 2-piece Config Endurant IIs 3-piece Config Endurant II AUI 2-piece AUI Config

6 Design: key differences between Endurant II/IIs Endurant II Endurant IIs Shortened ipsilateral leg _ 20mm longer than the C/L leg 4 internally sewn limb stents on ipsilateral leg Second marker at distal end of ipsilateral leg Both leg diameters fixed at 14mm

7 Key Advantages of Endurant IIs Expand anatomical customization options Up to 20% reduction in distal diameter In situ sizing allowing a 3 5 stent overlap for adjustment during case Better precision in distal landing to avoid Type IB EL or hypogastric artery unintended coverage Easier pre-case planning to simplify sizing MUCH FEWER PARTS NUMBERS

8 The Endurant EndoGraft Has been available for clinical use for over 7 years Approved in the US > 4 years Numerous Reports of Versatility even in Hostile Anatomy Mostly Non IFU Cases Endurant

9 AH: Narrow Iliac arteries and Difficult Neck 4mm External Iliac arteries Deployment at SMA Good Seal Hepato-Renal Bypass Zero No neck Access below Occluded Bilateral Issues renal stents

10 LC: 85 year old with large AAA. 3mm Renals Essentially NO Neck Excellent Seal

11 LC: Also Small Diseased Iliac arteries + old Stent

12 MB: 76 year old. Bad neck and occluded REIA Right External Occluded 3 years 20mm Pre Post Endurant AUI and Fem - Fem

13 GD: 80 yo + Very Narrow Calcified distal Aorta 1 month 61x66 2 years 58x64 Endurant AUI and Fem - Fem

14 WB: Short Angulated Neck and very Tortuous 12 cm AAA 10 mm Neck, severely Tapered 95 degrees Angulation

15 RO: Very Short Neck 4 Years PET Completely Collapsed Adequate Seal and Good Comformability

16 GS: Small Tapered Neck Adequate Seal and Good Comformability

17 BS: Small 16mm Reverse Taper Neck Adequate Seal and Good Comformability

18 EB: Large Reverse Taper Angulated Neck 28 to 35 Over 10 mm Severely tortuous iliacs Adequate Seal and Good Comformability

19 JP: Neck Bulge Adequate Seal and Good Comformability

20 VP: Saccular Aneurysm in Neck

21 Endurant: Clinical Experience First In Man (EU trial) 40 Continued Access (EU) 40 ENGAGE Registry 1263 Internationally ~1700 Patients In Trials and Registries 175,000 implants worldwide In the U.S. IDE 150 AUI Arm 44 ENGAGE PAS: Post-Market 178

22 US IDE Trial 26 Sites in US. Non Randomized April 2008-May 2009 Imaging Core Lab Clinical Events Committee Primary Endpoints Safety: MAE rates at 30 days Efficacy: Successful AAA Treatment at 1 year. 150 patients 5 year follow-up

23 US IDE Trial Select Inclusion Criteria AAA 5 cm Neck length 10 mm Neck angulation 60 degrees Iliac Fixation length 15 mm Suitable Access

24 5 Year Data presented at SVS in Chicago June 2015 Expected to be Published in JVS in early 2016 J Vasc Surg 2011;54:601-8

25 Baseline Characteristics: US IDE Trial Mean age: 73.1 ± 8.0 y (min 52, max 88) Female, % Female 8.7 % Male, % Male 91.3 %

26 ASA Classification at Baseline: US IDE Trial ASA Classification N=150 Class I 2.0% Class II 49.3% Class III 48.7% Class IV 0%

27 Procedure Characteristics : US IDE Trial Duration in minutes (mean ± SD; N=150) ± 46.2 General anesthesia (%) 83.3% (125/150) Blood loss in ml (mean ± SD; N=149) ± Hours in ICU (mean ± SD; N=150) 6.2 ± 19.4 Hospital stay in days (mean ± SD; N=150) 2.1 ± 2.3

28 Procedural Results: US IDE Trial Successful Delivery & Deployment 99.3% (149/150) In one subject gate could not be cannulated after deployment main body. Device converted to AUI.

29 Midterm Results: US IDE Trial Treatment outcomes 1 Year 2 Year 3 Year 4 Year 5 Year Post-Implant Rupture 0% 0% 0% 0.8% * 0% Conversion to Open Repair 0% 0% 0% 0% 0% * One subject experienced a new Type I endoleak at the 3 year time frame which led to an aneurysm expansion. The subject refused intervention and voluntarily entered hospice, and expired on day 1212 due to an aneurysm rupture

30 Freedom from Aneurysm-Related Mortality Midterm Results: US IDE Trial Endurant FF ARM: 99.2% through 5 yrs AAA-Related Mortality Endurant: 99.2% ± 1.96*0.8% Number of subjects at risk: Days from Initial Procedure Freedom from Aneurysm Related Mortality 99.2% through 5 Years Rupture day 1212*

31 Midterm Results: US IDE Trial Durable Clinical Performance 5 Years Durability Markers 1 Year 2 Year 3 Year 4 Year 5 Year Type I/III Endoleak 0% 0% 0.9% 0% 0% Type II Endoleak 10.4% 10.7% 10.2% 9.6% 7.2% Migration 0% 0% 0% 0% 0% Stent Graft Wire Form Fracture 0% 0% 0% 0% 0%

32 Freedom from Secondary Endovascular Procedure US IDE Trial Endurant FF 2 nd Endurant: Procedures: 89.0% ± 1.96*2.7% 89.0% through 5 yrs Majority 2 nd Proc 1 st 2 YR Number of subjects at risk: Days from Initial Procedure Secondary Procedures Freedom from Secondary Procedures 6.0% 5.0% 4.0% 3.0% 2.0% 1.0% 0.0% 89.0% through 5 Years 4.8% 2.1% 2.3% 2.5% 1.9% 1 YR 2 YR 3 YR 4 YR 5 YR

33 US IDE Trial SIZE CHANGES Defined as 5 mm compared to 1 MONTH 1 Month 6 Months 53mm 37mm

34 AAA Diameter Changes: US IDE Trial 95.2% of Sacs Decreasing/Stable at 5 yr 1 Year 5 Year Increase 4.8% Decreas e 47.4% Stable 52.6% 2 Year Increase 2.3% Stable 29.8% Decreas e 65.5% Decreas e 61.7% Stable 35.9%

35 Summary US IDE Trial Results The Endurant Stent Graft demonstrates sustained clinical performance across key endpoints at 5 years: - 0% migration or conversion - Low rates of AAA Sac Enlargement (4.8%), 2 nd Procedures and EL - Significant AAA Sac Shrinkage (65.5%) - Only 1 Aneurysm-Related Mortality through 5 yrs (0.8%)

36 ENGAGE REGISTRY 1263 PATIENTS, 79 SITES, 30 COUNTRIES Largest contemporary EVAR registry with single manufacturer s stent graft WE CEEGI AP CAN LA MEA CHN Number of pts recruited Number of recruiting sites

37 ENGAGE REGISTRY 40% 35% 30% 35.5% Patient characteristics Real World Practice 25% 20% 15% 17.8% 16.2% 15.2% 10% 10,0% 10.6% 10.5% 5% 0% SVS 3 Outside IFU Symptomatic AAA AAA >7cm Proximal Neck Length 10mm- <15mm ASA IV Female

38 ENGAGE: Clinical Follow-Up + Imaging Visit Compliance 100% 90% 80% 98% 94% 92% 87% 88% 87% 79% 77% 85% 81% Follow-up Imaging 70% 60% 50% 40% 30% 20% 10% 0% 1 year 2 year 3 year 4 year 5 year

39 ENGAGE REGISTRY Technical Success 99.0% (1251/1263) Intra-operative Clinical Success Technical Success Freedom from intra-operative death Freedom from type I/III Endoleak (uncorrected) 97.6% (1233/1263) 99.0% (1251/1263) 100.0% (1263/1263) 98.6% (1239/1257)

40 ENGAGE REGISTRY Treatment Outcomes Through 4 Years low aneurysm-, device- and procedure-related mortality days N= days N= days N= days N=1231 All-Cause Mortality 7.5 % (95) 13.9% (175) 19.8% (250) 24.0% (296) Device-related 0.2% (2) 0.3% (4) 0.3% (4) 0.5% (6) Procedurerelated Both device- and procedurerelated Aneurysm-related mortality 0.7% (9) 0.8% (10) 0.8% (10) 0.9% (11) 0.1% (1) 0.2% (2) 0.2% (2) 0.2% (3) 1.4% (18) 1.5% (19) 1.5% (19) 1.6% (20)

41 ENGAGE REGISTRY Freedom from AAA-Related Mortality 98.3 % 4 yrs Days days No. at Risk No. of Events Kaplan-Meier Estimate

42 ENGAGE REGISTRY Low rates of conversion to open surgery and incidence of rupture through 4 years days N= days N= days N= days N=1231 Conversion to open surgery 0.6% (7) 0.8% (10) 0.9% (11) 1.1% (13) Rupture 0.2% (2) 0.3% (4) 0.5% (6) 0.9% (11)

43 ENGAGE REGISTRY Type I and III Endoleaks Endoleak (total) At 1 month At 1 year At 2 year At 3 year At 4 year N=1163 N=1079 N=902 N=740 N= % (152) 9.9% (107) 10.3% (93) 10.0% (74) 9.5% (62) Type I 1.3% (15) 0.4% (4) 0.9% (8) 1.4% (10) 2.0% (13) Type IA 0.8% (9) 0.2% (2) 0.3% (3) 0.7% (5) 0.8% (5) Type IB 0.5% (6) 0.2% (2) 0.6% (5) 0.7% (5) 1.4% (9) Type III 0.3% (3) 0.2% (2) 0.7% (6) 0.1% (1) 0.2% (1) Type I and/or III 1.5% (17) 0.6% (6) 1.6% (14) 1.5% (11) 2.2% (14)

44 ENGAGE REGISTRY Type II and IV Endoleaks At 1 month At 1 year At 2 year At 3 year At 4 year N=1163 N=1079 N=902 N=740 N=650 Type II 11.1% (129) 8.6% (93) 8.1% (73) 8.1% (60) 7.1% (46) Type IV 0.1% (1) 0.1% (1) 0% 0% 0% Undetermined 0.5% (6) 0.6% (7) 1.0% (9) 0.5% (4) 0.6% (4)

45 ENGAGE REGISTRY Through 1 year Through 2 year Through 3 year Through 4 year N=1243 N=1243 N=1243 N=1212 Proximal migration Stent graft occlusion Stent graft kinking 0% 0% 0% 0.1% (1) 3.5% (44) 3.8% (47) 3.9% (49) 4.1% (50) 2.3% (28) 2.4% (30) 2.4% (30) 2.6% (31)

46 ENGAGE REGISTRY Freedom from Secondary Endovascular Re-Interventions 87.1 % 4 yrs Days No. at Risk No. of Events

47 ENGAGE REGISTRY AAA Diameter Changes 4 Year Increase 10.8% Decreas e 60.3% Stable 28.9% 89.2% of AAAs remain stable or decrease in size

48 SUMMARY ENGAGE REGISTRY RESULTS Very low incidence of body device migrations Low rates of endoleak, both overall (9.5%) and type IA endoleak (0.8%) 89.2% of AAA sacs stable or decreasing in size Freedom from 2 nd procedures is 87.1%, most 2 nd procedures occur in the 1 st year

49 US IDE vs. ENGAGE: Durable; consistent performance in straight-forward and challenging anatomies US IDE 1 at 5 Yrs No ASA IV patients No patients outside IFU 99.2% freedom from aneurysm-related mortality 89.0% freedom from secondary procedure ENGAGE Registry 2 at 4 Yrs Yes ASA IV patients 17.8% patients outside IFU 98.3% freedom from aneurysm-related mortalit 87.1% freedom from secondary procedure

50 US IDE vs. ENGAGE: Consistent Performance in Straight-Forward and Challenging Anatomies AAA Sac Change at 5 Yrs US IDE Trial 1 Increas e 4.8% AAA Sac Change at 4 Yrs ENGAGE Real World 2 Registry Increase 10.8% Core Lab Decreas e 65.5% Stable 29.8% Site Reported Decrease 60.3% Stable 28.9% 17.8% Pts ouside IFU 95.2% Decrease >5 mm/stable 89.2% Decrease >5 mm/stable

51 Aorto-Uni-Iliac US IDE Trial More Women / Sicker patients 44 Patients Females 32% ASA III or IV 82% Successful Deployment 98% Mortality 2.3%

52 Aorto-Uni-Iliac US IDE Trial No aneurysm related mortality No Fractures No Migration No post-op Ruptures No Conversion to Open Repair No Limb Thrombosis No Type I or III endoleaks. 10.5% Type 1 year No sac increase > 5 mm. 37% 1 year

53 J Vasc Surg 2014;60:1452-9

54 Medtronic Future Generation Endurant EVO AAA Stent Graft Improve Vascular Access Improve Ease of Use 20 Fr 18 Fr 17 Fr 15 Fr Endurant Endurant II Endurant EVO Fr OD bifur profile Fr OD limb profile - Small, tortuous and calcified iliacs - Percutaneous option 3 piece stent graft system with variable overlap - In situ length sizing Delivery system enhancements - Better ergonomics - Eliminate tip recapture step - Added flush port for contrast injection

55 Endurant Evo Global Clinical Program Enrollment 30 sites worldwide 140 subjects (minimum 70 US) First patient in: April 2015 Design Prospective, multi-center, pre-market, nonrandomized, single-arm trial Endpoints Safety: Major Adverse Events (MAEs) within 30- days post-implantation Effectiveness : Technical success at index procedure and treatment success at 12-months

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