French medtech outfit STENTYS is commercialising in Europe the world’s first and only Self-Apposing® stent to treat acute myocardial infarction (AMI). The company has announced that it has received Investigational Device Exemption (IDE) approval from the U.S.FDA to conduct a pivotal clinical trial in the United States which, if successfully completed, will enable the Company to apply for marketing approval of the STENTYS Self-Apposing stent.
During a heart attack treatment procedure, the presence of a clot and the natural vessel contraction prevent cardiologists from determining the artery diameter with certainty. When selecting a conventional stent size, there is a risk of under sizing, causing malapposition, or oversizing, causing vessel wall injury; either leads to increased risk of heart attack recurrence.
The STENTYS Self-Apposing Stent is designed to address that ‘stent sizing dilemma’ by fitting into the contour of a blood vessel. The shape and diameter of the stent adapt as the vessel dilates and the initial clot dissolves during the post-AMI phase.
Under this IDE, up to 880 heart attack (ST-elevation myocardial infarction or STEMI) patients at 50 sites in the U.S. and worldwide will be enrolled in the APPOSITION V clinical trial. The randomised trial is designed to compare the clinical outcome of patients treated with the bare metal STENTYS Self-Apposing® Stent versus a stent already approved for use in this indication, the Abbott Multi-Link Vision™ stent, at 12 months after the procedure. The trial is expected to begin in early 2013.
“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,” said Gonzague Issenmann, Chief Executive Officer and co-founder of STENTYS. “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.”