Healthcare Industry News:  self-expanding 

Devices Interventional Cardiology Regulatory

 News Release - July 8, 2009

Stentys receives CE Mark approval

First disconnectable and self-expanding platform for coronary artery bifurcation treatment receives European regulatory clearance

“Six-month follow-up data from our ‘OPEN I’ clinical study showed no stent fracture under angiographic core laboratory analysis—a major achievement for our platform.” -- Gonzague Issenmann, co-founder and CEO of Stentys

PRINCETON, N.J. and PARIS--(HSMN NewsFeed)--Medical device pioneer Stentys, founded in 2006 to develop a new-generation stent designed for treatment of acute myocardial infarction (AMI) and coronary artery bifurcations, announced today that it has received CE Mark approval of its disconnectable and self-expanding platform for treatment of coronary artery bifurcations.

The Company also announced that six-month follow-up data from its ‘OPEN I’ clinical study demonstrated safety and efficacy of its disconnectable and self-expanding platform in treating coronary lesions close to a bifurcation.

The versatile Stentys platform has two features—self-expansion and disconnectability—that are designed to be unrivaled in the stent industry. The self-expanding feature insures optimal apposition in the critical initial hours and days after an AMI procedure by being constantly applied to the vessel surface during thrombus and vessel spasm relief, therefore avoiding malapposition, a significant concern to cardiologists. 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. Equally important, the Stentys platform is implanted by usual stenting techniques requiring no additional training.

“We are extremely pleased with the results of the ‘OPEN I study,” said Gonzague Issenmann, Stentys’ co-founder and CEO. “There were no deaths or reoccurrence of MI during the six-month follow-up period. In addition, there were no fractures of the device itself, and all stents were perfectly apposed to the treated vessels.”

“While the CE Mark approval for bifurcations certainly represents a very significant milestone for the Company, it is important to further note that Stentys has also launched an ambitious clinical program to demonstrate that AMI patients may be better-treated with the self-expanding Stentys device. This second indication, AMI, doubles the Company’s market opportunities,” added Jacques Séguin, M.D., Ph.D., co-founder and Chairman of Stentys and founder of CoreValve.

About Stentys

Based in Princeton, N.J., and Paris, Stentys intends to make treatment of complex blocked coronary arteries as simple and effective as a conventional stenting procedure. Stentys was co-founded by Gonzague Issenmann and Jacques Séguin, M.D., Ph.D., founder of CoreValve, which was acquired this year by Medtronic for $700 million plus earn-outs.

Source: Stentys

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