Stentys, a developer of stents to treat acute myocardial infarction (AMI), has begun the international Apposition III study of its self-apposing stent, with 50 patients already enrolled out of a total of 500.
The trial primary endpoint is Major Adverse Cardiac Events at 12 months post-procedure.
Stentys said that its stent when compared to conventional stents is self-apposing, i.e. it ‘fits snugly’ into the contour of a blood vessel, and its shape and diameter adapt to the anatomic changes of the coronary arteries during the post-AMI phase.
The Apposition II randomised trial compared the Stentys Self-Apposing Stent with a conventional, stent in patients suffering a heart attack and showed that, three days after an AMI, 28% of patients treated with conventional stents displayed malApposition and in contrast, none of the patients treated with the Stentys stent had stent malApposition.
Stentys CEO and co-founder Gonzague Issenmann said that based on the results of Apposition I and II, the clinical evidence is indisputable: malApposition, which is a known cause of early stent thrombosis and repeat AMI, can be eliminated with the use of our self-apposing stent.
"Apposition III, designed as a large scale single-arm prospective clinical study, will confirm that the Stentys stent is the solution for the treatment of heart attack patients," Issenmann said.