STENTYS : 16 May 2012: Apposition III Results
FOR IMMEDIATE RELEASE
05/16/2012| 01:33pm US/Eastern
Contact: Ronald Trahan, APR, President, Ronald Trahan
Associates Inc., +1-508-359-4005,x108
STENTYS Self-Apposing® Stent shows very low mortality at one
month in 1,000 high risk heart attack patients
APPOSITION III study results reveal mortality at 1.2%
compared to 3.5% in pooled analysis of conventional stents
PRINCETON, N.J., and PARIS, May 16, 2012 - 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 the definite results on the 1,000
patient APPOSITION III clinical study at one month after
treatment of a severe heart attack.
The 30-day rate of MACE (Major Adverse Cardiac Events) and
death were compared to a pooled analysis conducted by the
ACTION Study Group (Pitié-Salpêtrière Hospital, Prof. G.
Montalescot) of all prior recent trials with conventional
stents in heart attack patients.
APPOSITION III results showed a MACE rate of 3.5% when
conventional stents are at an average of 6%;
the death rate was 1.2% with STENTYS when compared to 3.5%
with conventional stents.
"When the current guideline on balloon post-dilation was
applied, the MACE rate was even lower at 2.5%, which is a
drastic improvement for our patients", commented Dr Giovanni
Amoroso, OLVG Hospital, Amsterdam, The Netherlands and
principal investigator of the study.
"These impressive clinical results validate our
Self-Apposing® Stent as the best solution for treating heart
attack patients in routine practice," said Gonzague
Issenmann, CEO and co-founder of STENTYS.
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
About the APPOSITION III Study
APPOSITION III is a prospective, single arm, multi-center (50
hospitals across Europe) post-market trial to assess the long
term performance of STENTYS Self-Apposing stent in routine
clinical practice in 1,000 patients suffering from
ST-Elevation Myocardial infarction ("STEMI"). The trial's
primary endpoint is Major Adverse Cardiac Events ("MACE") at
12 months. MACE is defined at as cardiac death, target vessel
re-MI, emergent CABG, or clinically- driven TVR by
percutaneous or surgical methods at 12 months. The trial's
secondary endpoints are MACE at 30 days and 24 months
post-procedure. The study completed enrolment in January
2012. After a preliminary analysis of the first
350 patients, the guideline on balloon post-dilation was
modified from a limitation (only when residual stenosis
30%, cohort A) to a general recommendation (cohort B).
MACE rate at 30 days was 3.5% for the whole study, and 2.5%
when post-dilation was applied. Mortality represented
1.2% on the whole study.
STENTYS expects to release the primary endpoint interim
results of the APPOSITION III study in 600 patients
Q4 2012 and the full results on 1,000 patients in H1 2013.
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. STENTYS has commenced marketing
activities in several European countries.
This announcement is not an offer for sale of securities in
the United States. The securities referred to herein have not
been offered or sold in the United States and may not be
offered or sold in the United States of America, except
pursuant to a registration statement under the U.S.
Securities Act of 1933, as amended (the "Securities
Act"), or pursuant to an exemption from registrations
thereunder. This press release is being issued pursuant to
and in accordance with Rule 135c under the Securities Act.
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