Updated 4:45 p.m. with competing device information at the bottom
Boston Scientific’s (NYSE:BSX) Epic stent system knocked its primary 9-month endpoints out of the park, according to data from the company’s Orion trial.
The company beat its target 17% goal for major adverse events associated with iliac stenting, touting a 3.4% MAE rate over 9 months for the "intent to treat" population in the study.
MAEs were defined as death within 30 days, heart attack during hospitalization, target vessel revascularization through 9 months and amputation through 9 months – there were no deaths reported in the first 30 days and no amputations during the 9 months observed, according to the release.
The Orion study data will be used to support an FDA application for the Epic system, which currently has investigational device status in the U.S.
"The Epic stent has been used successfully in Europe for several years and we look forward to offering the device to U.S. physicians upon FDA approval," Boston Scientific peripheral interventions president Jeff Mirviss said in prepared remarks. "Upon approval, the Epic stent along with the market-leading Express LD balloon-expandable iliac stent, would enable Boston Scientific to offer a complete line of advanced iliac solutions for physicians and patients."
The prospective trial involved 125 patients at 28 U.S. sites to study treatment for iliac artery disease, a form of peripheral artery disease in which a lack of proper blood flow can cause severe leg pain, according to the release.
Based on validated questionnaires, patients experienced significant improvements on evaluations of walking distance, speed and stair climbing. Ultrasounds showed that treated lesions remained open through the 9-month follow-up period.
The Epic device is a self-expanding nitinol stent system designed to keep blood vessels open while providing useful features to help physicians place it accurately in the vessel.
The device won CE Mark approval in the European Union in 2009, according to the release.
While Boston Scientific organizes its bid for Epic’s FDA clearance, other med-tech titans, such as Cook Medical, C.R. Bard (NYSE:BCR), Covidien Plc. (NYSE:COV) and Medtronic (NYSE:MDT), have their fingers in the market as well.
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.