Endurant II - Medtronic - Endovascular Therapies International

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.