Stentys commences enrollment in its comparative stent study

Medical device pioneer Stentys announced today that the first patient has been enrolled into the ‘APPOSITION II’ clinical study—a randomized trial comparing the Stentys self-expanding stent with a conventional balloon-expandable stent in AMI patients. 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 first APPOSITION II case went extremely well,” said Prof. Christian Spaulding, M.D., Ph.D., chief of interventional cardiology at Cochin Hospital, Descartes University, Paris. “Three days later, thrombus and spasm had resolved, and the stent was perfectly apposed under OCT. This represents a breakthrough for successfully treating AMI.”

“We have already demonstrated how the Stentys stent adapts perfectly to the changing vessel anatomy following AMI stenting. We are convinced that the APPOSITION II study will further validate its superiority over existing stents to treat AMI patients,” said Gonzague Issenmann, CEO and co-founder of Stentys, “and thereby substantiate that all AMI patients should be treated with our self-expanding technology.”

The self-expanding feature of the Stentys platform, unrivaled in the stent industry, is designed to insure optimal apposition of a stent in the critical initial hours and days after an AMI procedure, by being continuously applied to the vessel’s internal surface even during thrombus and vessel spasm relief—thereby avoiding malapposition, a significant concern to cardiologists.