Stentys Platform Approved in Europe to Treat Bifurcations

July 8, 2009—Stentys, Inc. (Princeton, NJ) announced that it has received CE Mark approval of its disconnectable and self-expanding platform for treating coronary artery bifurcations. The company also announced that 6-month follow-up data from its OPEN I clinical study demonstrated safety and efficacy of the platform in treating coronary lesions close to a bifurcation.

According to the company, the Stentys platform's self-expanding feature insures optimal apposition in the critical initial hours and days after an acute myocardial infarction procedure by being constantly applied to the vessel surface during thrombus and vessel spasm relief, therefore avoiding malapposition. The disconnectability feature is designed to treat lesions close to a bifurcation, by ensuring safe main branch provisional stenting and optimal side branch access when needed. The Stentys platform is implanted by usual stenting techniques requiring no additional training, the company noted.