PRINCETON, N.J. and PARIS -  STENTYS, a medical technology company that is commercializing in Europe the world's first and only  Self-Apposing® stent to treat acute myocardial infarction (AMI), announced today that the first patient was enrolled in APPOSITION V, the pivotal FDA-approved IDE trial which will enable the Company to apply for marketing approval of the Self-Apposing Stent in the United States.

APPOSITION V is a multi-center, randomized, two-arm clinical trial that will enroll up to 880 heart attack (ST-elevation myocardial infarction or STEMI) patients at 50 sites in the U.S. and worldwide. The trial is designed to compare the clinical outcome of patients treated with the STENTYS Self-Apposing Stent with a balloon-expandable stent already approved for this indication, the Abbott Multi-Link stent, at 12 months after the procedure. Principal investigators of the study are Roxana Mehran, M.D., Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at Mount Sinai School of Medicine (New York), and Maurice Buchbinder, M.D., Professor of Clinical Medicine at Stanford University (Stanford, Calif.).

"The APPOSITION V trial will be a landmark study as it is the first time a novel device, that has already shown impressive clinical results in Europe, will benefit our STEMI patients here in the U.S." said Dr. Mehran. "We would like to congratulate Dr. Karel Koch from Amsterdam Medical Center for enrolling the first patient in this study."  

"This is a historic milestone for STENTYS, as we begin the U.S. trial that will allow us to file our marketing application with the FDA," said Gonzague Issenmann, CEO and co-founder of STENTYS. "The STENTYS Self-Apposing Stent has the potential to replace the current gold standard of conventional balloon-expandable stents in the AMI setting.

Source: STENTYS