Medical device pioneer Stentys announced today the results on 20 patients participating in the Company’s ‘APPOSITION I’ clinical study—the world’s first to treat patients with acute myocardial infarction (AMI) via a self-expanding stent. These data were disclosed today by the study’s principal investigator, Christian Spaulding, M.D., Ph.D., to an audience of cardiologists during a Stentys-hosted satellite meeting at the Transcatheter Cardiovascular Therapeutics (“TCT”) 2009 annual scientific meeting.
“The data from the APPOSITION I study is striking on two accounts,” said Prof. Spaulding, chief of interventional cardiology at Cochin Hospital, Descartes University, Paris. “First, we observed a statistically significant dilation of the vessel in the thrombotic lesion and its distality under IVUS, between treatment and three days post-procedure. Secondly, we were extremely pleased to see that the self-expanding Stentys stent remained in complete apposition with the vessel—in spite of the changing anatomy within the procedural vessel. This represents a potential breakthrough for successfully treating AMI.”
“We are thrilled by the results presented today,” said Gonzague Issenmann, CEO and co-founder of Stentys. “With 100% procedural success and no MACE reported up to 30 days, we are aggressively pursuing our APPOSITION program with the upcoming start of a randomized study of the Stentys self-expanding stent versus a balloon-expandable stent to treat AMI.”
“These initial results demonstrate that a self-expanding stent can fully embrace the growth in vessel lumen following the relief of the acute coronary syndrome that a balloon-expandable stent is simply not engineered to do,” added Jacques Séguin, M.D., Ph.D., Chairman of Stentys. “The next question we all need to answer is whether malapposition caused by balloon-expandable stents is acceptable.”
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.