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