STENTYS initiates enrollment in Self-Apposing Sirolimus-eluting stent trial for heart attack

STENTYS S.A. (STNT.PA), a medical technology company commercializing the world's first and only Self-Apposing® Stent to treat Acute Myocardial Infarction (AMI), announced today 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 Dr. 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.