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Stentys Bags CE Mark For Self-expanding Stent

Stentys has received CE marking for its self-expanding and disconnectable stent to treat acute coronary syndrome (ACS).

Stentys said that the self-expanding feature of the Stentys platform has been designed to ensure optimal apposition of a stent in the critical initial hours and days after an acute myocardial infarction (AMI) procedure. This is done by being continuously applied to the vessel’s internal surface even during thrombus and vessel spasm relief thereby avoiding malapposition, an important concern to cardiologists.

Gonzague Issenmann, co-founder and CEO of Stentys, said: “For European regulatory approval we have demonstrated how the Stentys stent perfectly conforms to a variable vessel anatomy after AMI stenting.

“Our strategy is to expand clinical evaluation with our ‘Apposition II’ clinical study. This is a randomized trial comparing the Stentys self-expanding stent with a conventional balloon-expandable stent in AMI patients, using extremely high-resolution OCT (optical coherence tomography) imaging to validate endpoints.”

Stentys intends to make treatment of complex blocked coronary arteries as simple and effective as a conventional stenting procedure. The company has announced in December 2009 that it has started enrolling patients in the randomized Apposition II clinical trial to compare its self-expanding stent against conventional stents in treating AMI patients, looking specifically at stent apposition and adaptation to vessel growth.

Stentys has been co-founded by Gonzague Issenmann and Jacques Seguin, founder of CoreValve, which was acquired in prevoius year by Medtronic for $700m plus earn-outs.