On 6 June 2012, Medtronic announced the US launch of the Endurant II Abdominal Aortic Aneurysm Stent Graft System, which recently received approval from the FDA for the minimally invasive treatment of abdominal aortic aneurysms through endovascular repair (EVAR).
The Endurant II System will be showcased at the Society for Vascular Surgery’s Vascular Annual Meeting, 7–9 June at National Harbor, near Washington, DC. Clinical performance updates on Medtronic’s entire portfolio of aortic stent grafts will also be presented at the meeting.
According to Medtronic, the Endurant II stent graft builds on the proven performance of the market-leading Endurant 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 18F outer diameter catheter (down from 20F 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.
“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 William Jordan, professor and chief of vascular surgery and endovascular therapy at the University of Alabama and one of the principal investigators for the US 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.”
The original Endurant stent graft received FDA approval in December 2010 and quickly became the US market leader, according to Medtronic. The next-generation Endurant II stent graft received the CE mark in December 2011 and has replaced the preceding version in Western Europe, while maintaining the preeminent market position that had been held by the Endurant stent graft since 2008. Overall, 70,000 patients worldwide have been treated with the Endurant product line.
FDA approval of Endurant II is based on the results of the US 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% of patients at two years.