Stentys Self-Expanding Stent Approved in Europe to Treat Acute Coronary Syndromes

March 5, 2010—Stentys, Inc. (Princeton, NJ) announced that it has received CE Mark approval for its self-expanding and disconnectable stent to treat acute coronary syndromes.

According to the company, the self-expanding feature is designed to ensure optimal apposition of a stent in the critical initial hours and days after an acute myocardial infarction procedure. The device avoids malapposition because it is continuously applied to the vessel's internal surface even during thrombus and vessel spasm relief.

The company intends to expand clinical evaluation with the APPOSITION II clinical study, a randomized trial comparing the Stentys self-expanding stent with a conventional balloon-expandable stent in acute myocardial infarction patients, using extremely high-resolution optical coherence tomography imaging to validate endpoints.