PRINCETON, N.J. & PARIS–(BUSINESS WIRE)–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.
About the APPOSITION IV Study
APPOSITION IV is a prospective, randomized, two-arm, multi-center study
designed to compare the apposition of the STENTYS Sirolimus-eluting stent with
Medtronic Resolute in 150 patients suffering from ST-elevation Myocardial
Infarction. Patients will be followed up at either 4 or 9 months (double
randomization). The powered primary endpoint is strut apposition at 9 months
under OCT. The secondary endpoints are strut apposition at 4 months under OCT,
and strut coverage at 4 and 9 months. The trial enrollment is expected to be
completed before the end of 2012, and the final results to be announced in H2
2013. The Sirolimus-eluting STENTYS stent CE Mark is expected in H2 2014.
About STENTYS
Based in Princeton, N.J.,
and Paris,
STENTYS has developed a new generation of stents to treat acute myocardial
infarction (AMI). Founded by Jacques Séguin, M.D., Ph.D., (also founder of
CoreValve, which was acquired by Medtronic) and Gonzague Issenmann, STENTYS
received CE-marking for its flagship products in 2010. Its Self-Apposing® stent
adapts to the anatomic changes of arteries in the post-infarction phase and
thus prevents the malapposition problem associated with conventional stents.
The APPOSITION III study showed very low mortality at one month in 1,000 high
risk heart attack patients. STENTYS has commenced marketing activities in
several European countries.
