Stentys Discloses Results for World's First Clinical Study to Treat Acute Myocardial Infarction (AMI) with a Self-Expanding Stent.Adaptation to vessel growth with perfect apposition apposition /ap·po·si·tion/ (ap?o-zish´un) juxtaposition; the placing of things in proximity; specifically, the deposition of successive layers upon those already present, as in cell walls. are key take-aways of the study PRINCETON, N.J. & PARIS Paris, in Greek mythology Paris or Alexander, in Greek mythology, son of Priam and Hecuba and brother of Hector. Because it was prophesied that he would cause the destruction of Troy, Paris was abandoned on Mt. -- 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 acute myocardial infarction (  ·kyōōtˑ mī·ō·karˑ·dē· (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 IVUS Intravascular ultrasound, see there , 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. 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 acute coronary syndrome n. A sudden, severe coronary event that mimics a heart attack, such as unstable angina. acute coronary syndrome that a balloon-expandable stent is simply not engineered to do," added Jacques Seguin, 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 thrombus /throm·bus/ (throm´bus) pl. throm´bi a stationary blood clot along the wall of a blood vessel, frequently causing vascular obstruction. and vessel spasm relief--thereby avoiding malapposition, a significant concern to cardiologists. About Stentys Based in Princeton, N.J., and Paris, Stentys intends to make treatment of complex blocked coronary arteries as simple and effective as a conventional stenting procedure. Stentys was co-founded by Gonzague Issenmann and Jacques Seguin, M.D., Ph.D., founder of CoreValve, which was acquired this year by Medtronic for $700 million plus earn-outs. |
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