The Apposition II trial involved 80 patients and was conducted in 6 European countries, between December 2009 and June 2010, which compares the Stentys self-apposing stent with a conventional stent in heart attack patients, to quantify one of the risks associated with conventional treatment, stent malApposition.
The trial showed that, three days after AMI, 28% of patients treated with conventional stents displayed malApposition which is not seen in patients treated with the Stentys stent.
The trial results demonstrate that the Stentys stent, due to its shape and diameter adapting to the anatomic changes of the coronary arteries during the post-AMI phase, eliminates malApposition and is therefore a safer solution than conventional stents for the treatment of heart attack patients.
Stentys CEO and co-founder Gonzague Issenmann said that the clinical evidence is indisputable and malApposition, a known cause of early stent thrombosis and repeat AMI, can be eliminated with the use of a self-apposing stent.
“This is the very first time that a clinical trial has investigated this issue, and the findings of the Apposition II study will be well-received by cardiologists worldwide who will see the Stentys stent as the solution to one of their key concerns with AMI patients,” Issenmann said.
