
Boston Scientific (NYSE:BSX) won pre-market approval from the FDA for its Epic self-expanding iliac stent.
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.
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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.