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Stentys Receives CE Marking 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 platform is designed to ensure optimal apposition of a stent in the critical initial hours and days after an acute myocardial infarction (AMI) procedure, by being continuously applied to the vessel’s internal surface even during thrombus and vessel spasm relief-thereby avoiding malapposition.

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.”