Stentys Heart Trial Enrolls First Patient

Stentys’ Apposition V trial to test its Self-Apposing stent to treat acute myocardial infarction (AMI), started last October, enrolled its first heart attack patient this month. Apposition V is a pivotal trial, and the stent has been granted an investigational device exemption from the U.S. Food and Drug Administration. The company’s goal for this trial is to gain marketing approval for the device in the United States.

The stent already is on the market in Europe, and Stentys’ CEO and co-founder Gonzague Issenmann attributed the company’s stellar growth last year to the success of the device.

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. In a STEMI, the coronary artery is completely blocked off by the blood clot, and as a result virtually all the heart muscle being supplied by the affected artery starts to die. 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, N.Y., 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 United States,” said 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 Issenmann. “The Stentys Self-Apposing stent has the potential to replace the current gold standard of conventional balloon-expandable stents in the AMI setting.”

Stentys is focused on developing and commercializing technology for the treatment of acute myocardial infarction and complex coronary artery disease. The company is based in Paris, France, with U.S. offices in Princeton, N.J.