Self-Expanding Stent Receives CE Marking
Medical device maker Stentys announced today that it has received CE Marking for its self-expanding and disconnectable stent to treat acute coronary syndrome (ACS).
According to the company, the self-expanding feature of the Stentys platform is designed to ensure optimal apposition of a stent in the 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.
“For European regulatory approval we have demonstrated how the Stentys stent perfectly conforms to a variable vessel anatomy after AMI stenting,” said Gonzague Issenmann, CEO and co-founder of Stentys. “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.”