Sep 23 2009
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.
http://www.stentys.com/
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