The expanded indication covers a new endovascular implantation approach using a parallel graft chimney approach called ChEVAR, which allows the device to be used to treat aneurysms with an aortic neck length of 2mm or more. Aortic neck length is the distance from the renal arteries to the aneurysm.
The ChEVAR approach, which uses balloon-expandable covered stents in the renal arteries and a stent graft in the aorta, is designed to increase the infrarenal “landing zone” for the stent graft. The Endurant II/IIs device was previously CE Marked for aortic neck lengths of 10mm or more, Fridley, Minn.-based Medtronic said.
The new indication was based on data from the Protagoras study using a standardized procedure in 128 patients that showed a 100% technical success rate, statistically significant aneurysm sac regression, 95.7% primary patency of the chimney grafts and a low incidence of chimney-related re-interventions, the company said.
“Medtronic is committed to partnering with our clinical community to provide solutions for challenging patients with complex aortic disease,” aortic business GM Daveen Chopra said in prepared remarks. “The expanded indication for our Endurant II/IIs stent graft system is a great example of how we can deliver solutions to address unmet clinical needs and improve standard of care for patients who have aneurysms with short neck lengths. We are excited to expand our leadership in EVAR with the first aortic stent graft approved for use with the ChEVAR technique.”
“Treating aneurysm patients with short aortic necks has been a long-time challenge for clinicians performing endovascular aneurysm repair (EVAR) to treat AAA patients,” added study co-author Dr. Giovanni Torsello of the St. Franzkisus Hospital in Mϋnster, Germany. “The availability of a standardized approach which increases anatomical applicability will help establish a new standard for patients with complex forms of AAA that may not have been suited for previous procedures.”
Endurant 1st won CE Mark approval in 2008. Medtronic said it plans to roll out the ChEVAR procedure in Europe and follow in other jurisdictions that recognize the mark. Endurant was approved in the U.S. in December 2010 for the 10mm aortic neck length indication but not for the ChEVAR approach.