June 15, 2012 — Stentys SA, a medical technology company commercializing the world's first and only self-apposing stent to treat acute myocardial infarction (AMI), announced that it has enrolled the first patient in its APPOSITION IV clinical study using its new self-apposing sirolimus-eluting stent. The randomized study will enroll 150 heart attack patients who will be treated with either the Stentys stent or Medtronic’s resolute drug-eluting stent, and will compare stent apposition in both groups at four and nine months after treatment.
Conventional drug-eluting stents have shown a high rate of persistent malapposition several months after heart attack treatment. This malapposition can trigger stent re-clotting, recurrence of the heart attack and possible subsequent death years afterwards.
"Long-term malapposition of drug-eluting stents has been associated with late stent thrombosis, so this randomized trial with the new Stentys sirolimus-eluting self-apposing stent will be carefully followed by the community," said William Wijns, co-principal investigator of the study and chairman of EuroPCR.
“Following the excellent results from the APPOSITION III study, we are going to add the Sirolimus-eluting stent to our portfolio and combine the best stent platform with a proven drug from the limus family,” said Gonzague Issenmann, CEO and co-founder of Stentys. “Cardiologists will have access to Stentys stents eluting the two compound families available on the market.”
The Stentys self-apposing stent solves the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients with conventional stents. It “fits snugly” into the contour of a blood vessel, and its shape and diameter adapt as the vessel dilates and the initial clot dissolves during the post-AMI phase, eliminating malapposition and its major complications seen with all other conventional stents.
For more information: www.stentys.com