Medtronic (NYSE:MDT) has received U.S. Food and Drug Administration approval for another kind of stent system for the treatment of peripheral artery disease — its Assurant Cobalt Iliac Balloon-Expandable Stent System.
The regulatory win for Medtronic’s Cardiac and Vascular Group comes a week after an FDA panel recommended against the approval of one of its cardiac ablation systems for atrial fibrillation.
Leveraging the strength of cobalt chromium with a thin, round, edgeless design gives the new stent optimal conformability to the wall of the vessel and allows for smooth delivery to iliac artery lesions, the company said in a statement. It complements Medtronic’s self-expanding Complete SE Vascular Stent, which was FDA approved in March 2010.
“By offering two stents for the treatment of narrowed iliac arteries, interventionalists who treat peripheral vascular disease now have more options to address their patients’ various clinical needs,” said Medtronic spokesman Joe McGrath.
Stents have been a source of growth for Medtronic recently. According to the company’s first-quarter earnings statement in August, revenue for Medtronic’s Endovascular & Peripheral business grew 16 percent, driven by the launch in the United States of the Endurant stent graft for abdominal aortic aneurysms and the availability of drug-eluding balloon stents in international markets.