CE Mark And Launch For Medtronic’s Endurant® II AAA Stent Graft System

“Building on the exceptional clinical outcomes of the original system, which has significantly increased the applicability of EVAR, Endurant II offers an even better user experience which will benefit even more patients whose AAAs are detected before rupturing.”

Abstract

Medtronic Inc. has announced the achievement of CE mark status and corresponding international launch of its Endurant® II AAA Stent Graft System.  The device succeeds the original Endurant graft and according to the company offers additional design features intended to improve ease of use in endovascular aortic repair (EVAR).

Background

Medtronic claims to offer the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. Developed in collaboration with more than 250 physicians from around the world, the new Endurant II system encompasses the proven clinical performance of the market-leading Endurant stent graft platform, while adding advanced design features that enhance the device’s ease of use.

Now to be made available through Medtronic’s direct or distributor operations in most European counties, the Endurant II AAA Stent Graft System follows its predecessor with three distinct enhancements to enable both the most straightforward and challenging cases:

  • Beginning at the point of access, the new lower-profile delivery system –– with 35 percent extended hydrophilic coating for enhanced access to challenging anatomies –– allows the 28mm-diameter bifurcated segment (the most commonly used size) to fit inside an 18 French OD (outer diameter) catheter (down from 20 French with the original device).
  • Second, the addition of two new contralateral limb lengths (156mm and 199mm) enables more configuration options requiring fewer total pieces.
  • Finally, the radiopacity of the distal end of the bifurcated segment’s contralateral gate has been improved to enhance visibility and aid with limb insertion, placement and deployment.

Clinician comments

“The Endurant II AAA Stent Graft System will confer considerable confidence to vascular surgeons who use EVAR to treat even the most complex AAAs,” said Prof. Hence Verhagen, chief of vascular surgery at the Erasmus Medical Center in Rotterdam, the Netherlands. “Building on the exceptional clinical outcomes of the original system, which has significantly increased the applicability of EVAR, Endurant II offers an even better user experience which will benefit even more patients whose AAAs are detected before rupturing.”

Prof. Verhagen, who led the European clinical trial of the original Endurant Stent Graft that contributed to that device’s approval, was the first physician to successfully use the new system since it received the CE mark.

Indications

In countries where the Endurant II Stent Graft is approved with the CE mark, the device is indicated for the endovascular treatment of abdominal aortic aneurysms in patients with a proximal neck ≥ 10 mm in length with ≤ 60° infrarenal and ≤ 45° suprarenal angulation and in patients with a proximal aortic neck ≥ 15 mm in length with ≤ 75° infrarenal and ≤ 60° suprarenal angulation.

FDA approval to follow

Medtronic says it expects to receive FDA approval for the new product during 2012, the original system already having been available since December 2010.