The US Food and Drug Administration has granted investigational device exemption (IDE ) to Stentys to initiate a pivotal clinical study of its Self-Apposing stent, for the treatment of de novo stenotic lesions in coronary arteries.
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-centre, prospective, randomised, two-arm study will enroll 880 ST-elevation myocardial infarction (STEMI) patients to compare the safety and effectiveness of the Self-Apposing stent with Abbott Vascular’s Multi-Link Vision coronary system.
The primary endpoint is target vessel failure (TVF), defined as target vessel recurrent myocardial infarction or clinically driven target vessel revascularisation (TVR) at 12 months post-procedure.
The secondary endpoint, acute stent malapposition, will be assessed by intravascular ultrasound (IVUS) on the first 225 patients.
Those implanted with the Self-Apposing stent will also undergo clinical follow up at six months, nine months and 12 months and receive annual checkups for three years.
The company hopes to begin enrolment in early 2013.
STENTYS chief executive officer and co-founder Gonzague Issenmann said the IDE enables the company to move towards bringing the self-apposing technology to cardiologists and their AMI patients in the US.
"With an AMI global market estimated at $2bn, 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 said.