The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to STENTYS to conduct a pivotal APPOSITION V clinical study for its Self-Apposing stent.
The Self-Apposing technology, which adapts vessels with ambiguous or fluctuating diameters particularly in the post-infarction phase, is designed to prevent risk of malapposition and vessel wall injury problems.
The multi-center, prospective, randomized, two-arm study, which will enroll 880 ST-elevation myocardial infarction (STEMI) patients, is designed to compare the safety and effectiveness of the Self-Apposing stent with Abbott Vascular’s Multi-Link Vision coronary system.
The primary endpoints for the trial is target vessel failure, defined as target vessel recurrent myocardial infarction or clinically driven target vessel revascularization (TVR) at 12 months post-procedure.
The secondary endpoint of acute stent malapposition will be assessed by intravascular ultrasound on the first 225 patients.
Patients implanted with Self-Apposing stent will also undergo clinical follow up at six months, nine months and 12 months as well as annual checkup through three years.
STENTYS chief executive officer and co-founder Gonzague Issenmann said the IDE allows the company to progress toward a pre-market application to bring the self-apposing stent to cardiologists and their AMI patients in the US.
"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," Issenmann added.
The company said the enrollment is expected to begin in early 2013.