Stentys has reported the first patient enrollment in the Apposition II clinical study, a randomised trial comparing the Stentys self-expanding stent with a balloon-expandable stent in AMI patients.
Reportedly, the primary endpoint of the Apposition II study is stent strut apposition at day three post-procedure via extremely high-resolution OCT (optical coherence tomography) imaging.
The company claims that the self-expanding feature of the Stentys platform, is designed to insure optimal apposition of a stent in the critical initial hours and days after an AMI procedure.
Gonzague Issenmann, CEO and co-founder of Stentys, said: “We have already demonstrated how the Stentys stent adapts perfectly to the changing vessel anatomy following AMI stenting.”
Christian Spaulding, chief of interventional cardiology at Cochin Hospital, Descartes University, said: “The first Apposition II case went extremely well. Three days later, thrombus and spasm had resolved, and the stent was perfectly apposed under OCT. This represents a breakthrough for successfully treating AMI.”