Medtronic (NYSE:MDT) said Tuesday that the U.S. Food and Drug Administration has approved its Endurant system to treat abdominal aortic aneurysms (AAA).
The company, based in Fridley, Minnesota, said the Endurant stent, inserted into the body through a catheter, can prevent sacs of blood from bursting in the body’s midsection by expanding the walls of the artery and relieving pressure on the bulge. Medtronic estimates 1.2 million Americans suffer from AAA, an often fatal disease that displays no obvious symptoms.
The Edurant 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.
“With FDA approval of Medtronic’s Endurant stent graft, U.S. physicians now have access to a new-generation device that will allow safe treatment of even more complex AAA patients with [endovascular repair] than was feasible with previous devices,” Dr. Michel Makaroun, professor and chief of vascular surgery at the University of Pittsburgh Medical Center, said in a statement.
“With its innovative design and delivery system,the Endurant stent graftrepresentsanother significant advance that expands our toolkit for the minimally invasive management of this dangerous, often deadly, condition,” Dr. Makaroun, who lead the clinical trial, said.
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