You can address sac regression with Endurant™ II/IIs Stent Graft System

Why sac regression?

  • Sac regression is defined by the SVS as the reduction in maximum diameter of the aneurysm sac by ≥ 5 mm.1
  • Latest clinical signals suggest aneurysm sac regression is associated with better long-term outcomes.2
Alert Indications, Safety, and Warnings

Addressing sac regression factors with Endurant

Endurant stent graft has demonstrated low type I and type II endoleaks in broad patient anatomies, with3,4:

  • Accurate placement and controlled deployment*
  • Continuous seal, fixation, and graft conformability*
  • Durable hemostatic barrier and resistance against type II endoleaks5

Sac regression features and benefits video - (02:25)

Endurant II/IIs is designed to provide continuous seal in a dynamic environment†

Methodology:
Radial force and micro-CT scans were tested by an independent lab to model Endurant's performance in the proximal seal zone through the cardiac cycle.

Results:
M-stent maintains even distribution of contact pressure, resulting in optimal conformability in a pulsatile environment.

See the Endurant II/IIs system perform in a dynamic environment.*

Normalized contact pressure in systole (120 mm Hg)*

Heat map of proximal M-stent on the Endurant II/IIs AAA stent graft showing even distribution of contact pressure

EVAR success

Aneurysm sac regression is a key indicator2 for EVAR success.

Dr. Ross Milner, Professor of Surgery, Co-director, Center for Aortic Diseases at the University of Chicago, discusses his thoughts on aneurysm sac regression post-EVAR.

Dr. Ross Milner discusses post-EVAR success - (01:55)

A new paradigm shift

Hear physicians' thoughts on aneurysm sac regression post-EVAR ― watch the on-demand webcast.

  • Moderated by Prof. Jean-Pierre Becquemin, M.D.
  • Panel includes Prof. Hence Verhagen, M.D., Ph.D., Prof. Michel Reijnen, M.D., Ph.D., and Prof. Apostolos Tassiopoulos, M.D.

"If you have sac shrinkage in the first year, the need for secondary interventions and therefore the need for intensive follow-up is different than those that don’t shrink."

–Prof. Hence Verhagen, M.D., Ph.D.

Aneurysm sac regression post-EVAR webinar - (05:37)

Watch Full Webcast on Academy

Clinical evidence VQI data

Latest data suggests aneurysm sac regression is associated with better long-term outcomes.2

Cohort that demonstrated sac regression at 1 year had significantly better outcomes than stable and expanding sac cohorts.

Freedom from all-cause mortality

VQI data chart suggesting aneurysm sac regression is associated with better long-term outcomes

Endurant data sac regression associated with better long-term outcomes

ENGAGE OUS Registry confirms sac regression link to better long-term outcomes. Patients with regressing sacs at 1 year had statistically significant better freedom from (FF) all-cause mortality (ACM) and FF secondary endovascular reinterventions than patients with stable or expanding sacs.6

In addition, ENGAGE OUS Registry 8-year data is available. The new standard for EVAR durability.7

See the 8-year data

Freedom from all-cause mortality

Graph of the ENGAGE OUS study confirming aneurysm sac regression link to better long-term outcomes

Freedom from secondary endovascular reinterventions

Graph of the ENGAGE OUS study shows patients with regressing aneurysm sacs at one year had significantly better outcomes

Endurant data consistent high sac regression rates

Endurant demonstrates consistent and high sac regression rates across straightforward and complex anatomies. New data suggests that patients with sac regression at 1 year appear to continue to have sac regression at 5 years.*

1-year sac regression is indicative of 5-year sac dynamics

Of those with sac regression at 1 year:

  • 86% of patients with images at 5 years continue to have sac regression
  • 2% have sac increase at 5 years

5Y sac regression rates§

Endurant chart demonstrating consistent sac regression rates in straightforward and complex patient anatomies

Percent of patients at imaging follow-up6

Chart suggesting that patients with sac regression at one year appear to continue to have sac regression at 5 years

Challenging EVAR procedure video case study

Dr. Ross Milner reviews the case of a challenging EVAR patient that resulted in a regressing aneurysm sac.

Case study of aneurysm sac regression with the Endurant II/IIs stent graft - (04:00)

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*

Medtronic data on file with reference UC201909791aEN Claims matrix.

†

Bench test data may not be indicative of clinical performance. Performance may vary upon use. Medtronic data on file with reference UC201909791aEN Claims matrix.

‡

P < 0.01 for comparisons to the Regression group.

§

Sac regression defined as the reduction in maximum diameter of the aneurysm sac by ≥ 5 mm for the ENGAGE OUS Registry Full Cohort. Other studies cited use a threshold of > 5 mm.

||

Medtronic data on file (PASR 2020).

References

1

Ahn SS, Rutherford RB, Johnston KW, et al. Reporting standards for infrarenal endovascular abdominal aortic aneurysm repair. Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/International Society for Cardiovascular Surgery. J Vasc Surg. February 1997;25(2):405-410.

2

O’Donnell TFX, Deery SE, Boitano LT, et al. Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long-term survival. J Vasc Surg. February 2019;69(2):414-422.

3

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. July 2016;64(1):55-62.

4

Teijink JAW, Power AH, Böckler D, et al. Editor's Choice - Five Year Outcomes of the Endurant Stent Graft for Endovascular Abdominal Aortic Aneurysm Repair in the ENGAGE Registry. Eur J Vasc Endovasc Surg. August 2019;58(2):175-181.

5

Wakefield TW, Shulkin BL, Fellows EP, Petry NA, Spaulding SA, Stanley JC. Platelet reactivity in human aortic grafts: a prospective, randomized midterm study of platelet adherence and release products in Dacron and polytetrafluoroethylene conduits. J Vasc Surg. February 1989;9(2):234-243.

6

Bӧckler D, Li C, Dansey K, et al. Sac regression is associated with lower all-cause mortality after contemporary endovascular aneurysm repair — a new paradigm for success. Presented online at ESVS 34th Annual Meeting, October 6, 2020.

7

Teijink J, Power A, van Sterkenburg S, et al. 8-Year Data from the ENGAGE Registry Extension: Insights About the Long-term Performance of A Contemporary EVAR Device. Presented online at ESVS 35th Annual Meeting. September 20, 2021.