Stentys SA (EPA:STNT) hoping a new U.S. clinical trial will help it win pre-market approval for a self-apposing coronary stent.
The Princeton, N.J.- and Paris-based medical device company said it enrolled the 1st patient in its Apposition V trial, under an investigational device exemption from the U.S. watchdog agency.
The randomized, 2-arm study will enroll up to 880 heart attack patients at 50 sites. Stentys is comparing patient outcomes with its self-apposing stent to Abbott’s (NYSE:ABT) multi-link stent out to 12 months.
"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," CEO Gonzague Issenmann said in prepared remarks. "The Stentys Self-Apposing Stent has the potential to replace the current gold standard of conventional balloon-expandable stents in the AMI setting."
In 2012, the company won its IDE for the trial. Stentys went head-to-head with Medtronic’s (NYSE:MDT) Resolute device in the Apposition Ive clinical study launched in 2012.