Stentys Self-Apposing Stent Approved in Europe for Additional Coronary Indications

July 10, 2013—Stentys (Princeton, NJ) announced that it received approval to expand the CE Mark-approved indications for the Stentys self-apposing stent, which is designed to treat acute myocardial infarction and patients with atypical artery anatomy.

According to Stentys, the CE Mark certification of the self-apposing stent was updated on the basis of additional clinical evaluation and now includes specific patient subsets such as those with tapered, aneurysmatic, ectatic (dilated), or very large vessels, or those with bypass grafts. Contraindications, such as chronic total occlusions and left main bifurcations, have also been lifted.

The device is engineered to solve the dilemma of artery diameter discrepancy with a flexible, self-expanding design that takes the shape of a patient's unique vessel anatomy and perfectly apposes to the irregular contours of a blood vessel, even as the vessel dilates and the initial clot dissolves after an acute myocardial infarction. It reduces the risk of malapposition and complications associated with conventional stents in this setting, the company stated.

The Stentys self-apposing stent has been commercially available in Europe since receiving CE Mark approval in 2010. On May 20, 2013, the company announced the beginning of enrollment in APPOSITION V, the pivotal trial conducted under an investigational device exemption to seek US Food and Drug Administration approval to market the Stentys self-apposing stent in the United States.