U.S. Launch For Medtronic’s Endurant® II AAA Stent Graft System

In short

Medtronic, Inc. has synchronised the U.S. launch of the recently FDA cleared Endurant® II AAA (Abdominal Aortic Aneurysm) Stent Graft System with the Society for Vascular Surgery’s Vascular Annual Meeting being held right now. The system is indicated for the minimally invasive treatment of AAA through endovascular repair (EVAR), an alternative to major surgery.

Background

Medtronic’s original Endurant AAA Stent Graft received FDA approval in December 2010 and quickly became the U.S. market leader. The next-generation Endurant II AAA Stent Graft received CE Mark approval in December 2011, as we reported here, and has replaced the preceding version in Western Europe, while maintaining the preeminent market position that had been held by the Endurant AAA Stent Graft since 2008.

Medtronic states that overall, 70,000 patients worldwide have been treated with the Endurant product line.

FDA approval of the Endurant II AAA Stent Graft is based on the results of the U.S. clinical study of the predicate device, which continues to demonstrate strong clinical performance and efficacy in long-term follow-up. The outcomes at two-years showed no Type I endoleaks, migration, conversion to surgery, or aneurysm-related mortality. Furthermore, aneurysm sac diameter decreased or remained stable in 98.3 percent of patients at two years.

The Endurant II AAA System will be showcased at the Society for Vascular Surgery’s Vascular Annual Meeting, June 7­­-9 at National Harbor, Md., near Washington, D.C. Clinical performance updates on Medtronic’s entire portfolio of aortic stent grafts will also be presented at the meeting.

Endurant II vs Endurant?

The Endurant II AAA Stent Graft builds on the proven performance of the market-leading Endurant AAA Stent Graft, while adding three distinct features that enhance the device’s ease of use and options for clinical success:

  • A lower profile delivery system with an extended hydrophilic coating improves access. The 28mm-diameter stent graft (the most commonly used size) now fits inside an 18-French OD (outer diameter) catheter (down from 20 French in the original device).
  • Two new contralateral limb lengths (156mm and 199mm) provide more options in sizing and can reduce the number of pieces required for an EVAR case.
  • Improved radiopacity of the contralateral gate on the distal end of the device aids with limb insertion, placement and deployment.

Clinician comments

“The Endurant II Stent Graft is a very deliverable device that enhances the ability to treat more patients than previous devices and to traverse challenging anatomies, especially iliac arteries with tight access,” said Dr. William Jordan, professor and chief of vascular surgery and endovascular therapy at the University of Alabama and one of the principal investigators for the U.S. clinical study of the predicate device. “Considering the exceptional clinical performance of the original system, the Endurant II Stent Graft is even easier to use in both straightforward and challenging anatomies.”

Source: Medtronic Inc.