Stent maker Stentys SA (EPA:STNT) won FDA investigational device exemption to launch its 1st U.S. clinical trial of its Self-Apposing stent that it hopes to use in support of a premarketing approval bid.
The announcement was made as the company, in a separate release, unveiled interim results of its Apposition III trial during the Transcatheter Cardiovascular Therapeutics conference in Miami this week.
The FDA investigational device nod grants Stentys approval to enroll up to 880 heart attack patients across 50 sites in the U.S. and worldwide in the company’s 5th Apposition clinical trial.
The new study is a randomized trial designed to compare 1-year outcomes of patients treated with the bare metal Stentys Self-Apposing stent against medtech giant Abbott’s (NYSE:ABT) Multi-Link Vision stent. Stentys expects the study to begin early in 2013, according to a press release.
"With an AMI global market estimated at $2 billion, this IDE approval represents a significant milestone for the company and an opportunity to expand upon the data gathered to date in our European clinical trials," CEO & co-founder Gonzague Issenmann said in prepared remarks. "The IDE allows us now to progress toward a pre-market application to bring the self-apposing technology to cardiologists and their AMI patients in the U.S."
In a separate statement Stentys also announced interim results from an ongoing European single-arm study of the Self-Apposing stent in patient with ST-elevation myocardial infarction. The company plans to present the findings later this week during the TCT conference.
The company unveiled findings for the 1st 600 of its 1,000 patient study, reporting a 1.7% death rate at the 1-year mark which the company contrasts with the 3.9% average death rate established by a pooled analysis from the Action Study Group at the Pitié-Salpêtrière Hospital in Paris.