Stentys, which develops innovative stents to treat acute myocardial infarction (AMI), announced on 13 December 2010 that it has begun the international APPOSITION III study of its self-apposing stent, with 50 patients already enrolled out of a total of 500. The trial primary endpoint is major adverse cardiac events at 12 months post-procedure.
“The cardiologists in our cath lab are extremely excited to be part of the APPOSITION III study, because it allows us to use the Stentys self-apposing stent in a real-life setting for the treatment of AMI patients,” said study investigator Harald Mudra, head of the Department of Cardiology, Pulmonology and Internal Intensive Care Medicine of the Neuperlach Hospital in Munich, Germany.
“Based on the results of APPOSITION I and II, the clinical evidence is indisputable: malapposition, which is a known cause of early stent thrombosis and repeat AMI, can be eliminated with the use of our self-apposing stent. APPOSITION III, designed as a large scale single-arm prospective clinical study, will confirm that the Stentys stent is the solution for the treatment of heart attack patients,” added Gonzague Issenmann, CEO and co-founder of Stentys.
The Stentys stent represents a major breakthrough compared to conventional stents when treating heart attacks: it is self-apposing, i.e. it “fits snugly” into the contour of a blood vessel, and its shape and diameter adapt to the anatomic changes of the coronary arteries during the post-AMI phase. The APPOSITION II randomised trial compared the Stentys Self-Apposing Stent with a conventional, market-leading stent in patients suffering a heart attack. It showed that, three days after an AMI, 28% of patients treated with conventional stents displayed significant malapposition, meaning that the stent was not completely in contact with the artery wall. Malapposition puts AMI patients at significant risk of potential fatal complications such as a blockage of the stent (in-stent thrombosis). In contrast, none of the patients treated with the Stentys stent had stent malapposition.