Medtronic Inc. (NYSE:MDT) won Food & Drug Administration approval for its Endurant stent for abdominal aortic aneurysms.
The Fridley, Minn.-based medical device giant’s device, which is delivered via catheter through the femoral artery, won CE Mark approval in the European Union in 2008 and is in use in roughly 100 countries, according to Medtronic.
One advantage of AAA stenting is that it doesn’t require open surgery to remove the diseased section of blood vessel. Abdominal aortic aneurysms occur when a weak spot in the arterial wall forms a bulge. The Endurant stent reinforces the weak spot, reducing the amount of pressure against it.
One-year results of the pivotal study behind the PMA were reported last month. The 150-patient study showed no deaths after 30 days and no post-procedure ruptures or deaths for one year, according to MedPage Today. All patients showed either stable or shrinking aneurysms and the device performed well surgically.
The Endurant line has contributed to the 5 percent growth in cardiovascular revenue so far this year, Medtronic said in its latest earnings announcement. It was one of several new products — including the Resolute drug-eluting stent and Integrity bare-metal stent — that helped grow revenue.
Last month, the FDA approved Medtronic’s Talent Captiva stent graft system to treat aortic aneurysms, a much smaller market compared to AAA. An estimated 60,000 people in the United States suffer from the disorder in which a dangerous bulge develops in the main artery near the heart.
Material from MedCity News was used in this report.