The watchdog agency approved the device for treating de novo or restenotic symptomatic atherosclerotic lesions in the iliac arteries, according to agency documents released today.
The approval, which follows the successful conclusion of a clinical trial earlier this year, puts the Natick, Mass.-based med-tech titan in the company of other major players with similar devices: Cook Medical, C.R. Bard (NYSE:BCR), Covidien Plc. (NYSE:COV) and Medtronic (NYSE:MDT) all have their fingers in the iliac stent market.
Cook’s Zilver self-expanding nitinol stent vascular stent won U.S. market clearance in 2006, according to a press release. Bard’s E*Luminexx self-expanding nitinol stent vascular stent won FDA clearance in 2008.
More recently, Medtronic’s Assurant cobalt chromium balloon-expanded iliac stent system won FDA clearance in Oct. 2011, with Medtronic touting it as the first balloon-expandable CrCo stent approved for narrowed iliac arteries in the U.S.
Covidien enrolled the first patients into its two Iliac stent trials, Durability and Visibility, in Aug. 2011.