CLINICAL OUTCOMES Endurant II Stent Graft Systems

Only the Endurant™ II stent graft system has the deep clinical experience and favorable clinical outcomes designed to treat both challenging and straightforward anatomy. In the past 5 years, the Endurant II stent graft system has been used in 1 of every 2 EVAR cases, with use in more than 280,000 patients worldwide.^*

^*Data as of May 2017.

CLINICAL EXPERIENCE OVERVIEW*

Trials and Registries	Duration (years)	N (total patients: 1895)
EU TRIAL	1	80
France Post Approval	3	180
US Post Approval	4	178
ENGAGE Global Registry	5	1263
US IDE AUI Arm	5	44
US IDE Bifurcated Arm	5	150

^*Medtronic data on file. Data current as of August 2017.

EVENT RATES AT 30 DAYS ACROSS 1400+ PATIENTS

	Trial Study Design	Technical / Deployment Success (%)	Type I Endoleak (%)
EU Trial¹(N = 80)	Prospective, open-label, multicenter trial conducted at 10 sites across Europe.	100	0
US IDE²(N = 150)	Prospective, multicenter trial conducted at 26 sites across the United States. Reviewed by independent core lab.	99.3	0
ENGAGE Registry³(N = 1263)	Post-market, real-world registry involving 1263 patients at 79 sites in 30 countries.	99.4	1.2

¹ ENDURANT EU trial: Rouwet EV, et al. Eur J Vasc Endovas Surg 2011;42(4):489-497.

² ENDURANT US IDE trial: Singh MJ, et al. J Vasc Surg 2016;64:55-62.

³ ENGAGE Registry: Stokmans RA, et al. Eur J Vasc Endovas Surg 2012;44:369-375.

Engage Registry Milestone: 5 Years of Real World Clinical Excellence*

Description	%
Aneurysm Related Mortality^†	FF 97.8%
Secondary Endovascular Procedure^† (overall)	FF 84.3%
AAA Sac Diameter Stable or Decrease^‡	89.4%
Type 1a Endoleaks^‡	1.6%
Main Body Migration^‡	0.3%

^*ENGAGE 5-year data. Data on file at Medtronic.

^†Data reported through 5-year timeframe.

^‡Data reported at 5-year timeframe.

ENGAGE short neck analysis 5 years (cumulative)

The ENGAGE registry is the largest analysis of short AAA neck patients using a single contemporary EVAR device followed through 5 years.

Cumulative through 5-Years	10 mm – <15 mm (n=123)	≥15 mm (n=1100)
FF Secondary Endovascular Procedure^*	84.5%	84.4%
FF ARM^*	97.8%	97.8%
FF Type la Endoleak^†	90.9%	96.0%
FF Rupture^*	96.6%	98.7%
FF Conversion^*	96.5%	98.0%

^*Numbers are freedom from (FF) event survival estimate % based on Kaplan-Meier method.

^† Numbers are freedom from (FF) event survival estimate % based on Interval-Censored method.

RESULTS OF THE ENDURANT US IDE TRIAL¹

The Endurant II stent graft closes the outcomes gap between challenging and straightforward anatomies.

	1 Year	5 Year
Type I / III Endoleak	0.0% (0/132)	0.0% (0/73)
Type II Endoleak	9.1% (12/132)	4.1% (3/73)
Migration	0.0% (0/132)	0.0% (0/73)
Conversion	0.0% (0/132)	0.0% (0/73)
Secondary Procedure	95.3% FF	89% FF
Aneurysm-related Mortality	100% FF	99.2% FF

¹ Singh MJ, Fairman R, Anain P, et al. Final Results of the Endurant Stent Graft System in the United States Regulatory Trial. J Vasc Surg. 2016;64:55-62.

PROCEDURAL PERFORMANCE BEYOND CLINICAL PERFORMANCE

Outcomes from the US IDE Trial¹	At Implant
Successful Delivery and Deployment	99.3% (149/150)
Procedure Duration (minutes) (mean + SD; N = 150)	101.5 + 46.2
General Anesthesia	83.3% (125/150)
Blood Loss (mL) (mean + SD; N = 149)	185.8 + 168.0
ICU Stay (hours) (mean + SD; N = 150)	6.2 + 19.4
Hospital Stay (days) (mean + SD; N = 150)	2.1 + 2.3