Stentys has received investigational device exemption (IDE) approval from the 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 to treat acute myocardial infarction.
Under this FDA-approved IDE, up to 880 ST-elevation myocardial infarction (STEMI) patients at 50 sites in the USA 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 the 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 acute myocardial infarction global market estimated at US$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 acute myocardial infarction patients in the USA.”
The Stentys Self-Apposing Stent is designed to address the “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-acute myocardial infarction phase.
APPOSITION V is a prospective, multicentre, randomized, two-arm clinical trial to evaluate the safety and effectiveness of the Stentys Self-Apposing stent in the treatment of de novo stenotic lesions in coronary arteries in 880 patients undergoing primary revascularisation due to STEMI as compared to the Multi-Link Vision coronary system. The trial’s primary endpoint is target vessel failure, which is defined as a composite of cardiac death, target vessel recurrent myocardial infarction or clinically driven target vessel revascularisation at 12 months post-procedure. The powered secondary endpoint is acute stent malapposition and will be assessed by intravascular ultrasound on the first 225 patients. All patients will undergo clinical follow-up at 30 days and six, nine and 12 months, with an annual checkup through three years. Fifty sites are expected to participate in the USA and worldwide. Enrolment is expected to begin in early 2013.