Stentys Trumpets IDE For Study To Demo Benefit Of Stent That Adapts To Vessel Dynamics

In short

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.

Background

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.

Company comments

“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.”

Source: Stentys