Endurant II - Medtronic - Endovascular Therapies International

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DuRABLE DESIGN DEPENDABLE PERFORMANCE Featuring a suprarenal stent with anchor pins laser-cut from a single piece of nitinol and high-density polyester graft material, Endurant II is built for durability, with the quality you’ve come to expect. * 1. High-density, multifilament polyester graft material provides lower porosity for resistance against Type IV endoleaks 2. Ultra-high molecular weight polyethylene sutures are three times stronger than surgical sutures 1 10 ENDURANT II AAA STENT GRAFT SYSTEM With AAA EVAR Devices And How Are They Helping In Patient Treatment), VEITH 2011. 11 2 3 0.0%† Migration at 2 Years BEFORE POLISHING Suprarenal stent with anchor pins laser-cut from a single piece of nitinol provides secure fixation 3. Electropolished nitinol stent for greater strength * EU Trial, US IDE and ENGAGE Registry studied the Endurant AAA Stent Graft System. † Proximal migration is observed when the stent graft covers a renal artery or moves > 10 mm. Distal migration is observed when the stent graft moves > 10 mm relative to fixed anatomic landmarks. Makaroun M., US IDE 2-Year Presentation (What Improvements Have Occurred AFTER POLISHING
CLINICAL DATA BuILDING CONFIDENCE CONSISTENTLY LOW EVENT RATES. TRIAL AFTER TRIAL. 1 EvEnT RATEs AT 30 DAYs ACROss 1400+ PATIEnTs Eu TRIAL (N = 80) uS IDE (N = 150) ENGAGE REGISTRY 4 (N = 1200) Trial Study Design Prospective, open-label, multicenter trial conducted at 10 sites across Europe Prospective, multicenter trial conducted at 26 sites across the United States. Reviewed by independent core lab Post-market, real-world registry involving 1200+ patients and 80+ countries across six continents Technical / Deployment Success 2 (%) Type I Endoleak 3 (%) 100 0 99.3 0 99.4 1.2 ENDURANT EU trial: Rouwet EV et al. Final results of the prospective European trial of the Endurant stent graft for endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 2011;42(4):489–497. ENDURANT US IDE trial: Makaroun M. One-year outcomes of the US regulatory trial of the Endurant stent graft system. J Vasc Surg. 2011;54:601–608. ENGAGE Registry Schermerhorn M. ENGAGE 30-day and 1-year results, VIVA 2011. EnDURAnT II InDICATIOns 5 Prox Neck Length ≥ 10 mm with Infrarenal Angulation ≤ 60 and Suprarenal Angulation ≤ 45 Prox Neck Length ≥ 15 mm with Infrarenal Angulation ≤ 75 and Suprarenal Angulation ≤ 60 1. EU Trial, US IDE and ENGAGE Registry studied the Endurant AAA Stent Graft System. 2. EU Trial delivery success = successful vascular access and delivery of the device to the intended anatomical treatment site; EU Trial deployment success = successful deployment of the device in the intended site and the successful removal of the delivery system; US IDE deployment success = “successful stent graft implant.” 3. 30 Day EU Trial data represents follow-up on N = 79 patients. 30 Day US IDE data represents follow-up on N = 130 patients. 4. 30 Day ENGAGE data represents follow-up on N = 1194 patients. 5. Endurant II IFU EvEnT RATEs AT 1 YEAR 12 ENDURANT II AAA STENT GRAFT SYSTEM 12. Based on preliminary data received for 96% of eligible subjects at 2 years 13 Eu TRIAL (N = 80) (%) uS IDE (N = 150) (%) ENGAGE Registry (N = 1200) 6 (%) Type I endoleak 7 0 0 0 Migration 8 0 0 0 Aneurysm sac diameter: decrease or stable 97.3 100 97 Conversion to surgery 0 0 0.9 Aneurysm-related mortality (ARM) 9 Not Reported * 0 1.8 0% Post-Operative Rupture at 1 Year 10 * Freedom from All-Cause Mortality at 1 Year, the primary endpoint of clinical success was achieved in 95% of patients. 6. 1 Year ENGAGE data represents follow-up on N = 350 patients. 7. 1 Year EU Trial data represents follow-up on N = 77 patients. 1 Year US IDE data represents follow up on N = 130 patients. ENDURANT EU trial: Rouwet EV et al. Final results of the prospective European trial of the Endurant stent graft for endovascular abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 2011;42(4): 489–497. ENDURANT US IDE trial: Makaroun M. One-year outcomes of the US regulatory trial of the Endurant stent graft system. J Vasc Surg. 2011;54:601–608. 8. Proximal migration is observed when the stent graft covers a renal artery or moves > 10 mm. Distal migration is observed when the stent graft moves > 10 mm relative to fixed anatomic landmarks. 9. Aneurysm-related mortality is reported as “freedom from ARM” in the EU Trial. 10. Endurant EU Trial: E.V. Rouwet et. al. Final Results of the Prospective European Trial, Eur J Vasc Endovasc Surg, 2011 and Endurant US IDE Trial: M. Makaroun. One year outcomes of the US regulatory trial of the Endurant Stent Graft System. J Vasc Surg 2011; 54:601-8. COnsIsTEnTLY LOW EvEnT RATEs AT 2 YEARs 11 uS IDE TRIAL: 2 YEAR RESuLTS 12 Freedom from Secondary Procedure (N = 137) 93.9% Migration (N = 105) 0% Conversion to Surgery (N = 136) 0% Aneurysm-Related Mortality (N = 144) 0% 11. Makaroun M., US IDE 2-Year Presentation (What Improvements Have Occurred With AAA EVAR Devices And How Are They Helping In Patient Treatment), VEITH 2011.
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