Self-Expanding Stent Receives CE Mark to Treat Acute Coronary Syndrome


March 8, 2010

March 8, 2010 – A self-expanding and disconnectable stent today gained CE mark approval in Europe to treat acute coronary syndrome (ACS).

The Stentys 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, a significant concern to cardiologists.

For European regulatory approval the company demonstrated how the Stentys stent conforms to a variable vessel anatomy after AMI stenting during the APPOSITION II clinical study. This is a randomized trial comparing the Stentys self-expanding stent with a conventional balloon-expandable stent in AMI patients, and reviewed using extremely high-resolution OCT (optical coherence tomography) imaging to validate endpoints.

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