STENTYS to Present Final Results From 1,000 Heart Attack Patient Study at ACC.13

  STENTYS to Present Final Results From 1,000 Heart Attack Patient Study at
  ACC.13

 Educational Symposium Also to Highlight FDA-Approved U.S. Pivotal Study for
                   Self-Apposing^® Stent in STEMI Patients

Business Wire

PRINCETON, N.J. & PARIS -- February 26, 2013

STENTYS (FR0010949404 – STNT), a medical technology company commercializing in
Europe the world's first and only Self-Apposing^® Stent to treat acute
myocardial infarction (AMI), announced today that results for the primary
endpoint in the APPOSITION III study (MACE at one year on 1,000 STEMI
patients) will be presented during ACC.13, the American College of
Cardiology’s Scientific Session & Expo, March 9-11, 2013 in San Francisco.
Prof. Gilles Montalescot, M.D., Ph.D, Head of the Cardiac Care Unit at
Pitié-Salpêtrière Hospital (Paris), will present “One Year Clinical Results on
1,000 STEMI Patients Treated With a Self-Expanding Coronary Stent (APPOSITION
III)” during Session #2667 of the Featured Clinical Research I: Interventional
session on Saturday, March 9, 2013 at 3:00 p.m.

STENTYS is also hosting an educational symposium during ACC.13 that will
provide an overview of the Self-Apposing Stent clinical results to date and
the U.S. IDE trial in STEMI, APPOSITION V. The event, “STENTYS IDE Trial in
STEMI: The Self-Apposing Stent Revolution is Coming to the U.S.,” is being
held Sunday, March 10, 2013 from 6:45 a.m. to 7:45 a.m. at the
InterContinental San Francisco Hotel and features a panel discussion and
presentations relating to the Self-Apposing technology by prominent
cardiologists:

  *Maurice Buchbinder, M.D., of the Foundation for Cardiovascular Medicine
    (San Diego) will present “Better Stent Sizing Leads to Better Outcomes:
    The Self-Apposing Stent Technology.”
  *Karel Koch, M.D., of the Academic Medical Center, University of Amsterdam
    will present “Real-world Experience: Case Studies and APPOSITION III
    One-Year Results on 1,000 STEMI Patients.”
  *Roxana Mehran, M.D., of Mount Sinai Hospital (New York) will present
    “STENTYS Randomized IDE Trial in STEMI, the APPOSITION V Study in the
    United States and Worldwide.”
  *Timothy D. Henry, M.D., of the Minneapolis Heart Institute Foundation will
    also be participating in panel discussions.

About the STENTYS Self-Apposing^® Stent
The STENTYS Self-Apposing® Stent addresses the stent-sizing dilemma that
cardiologists are confronted with when treating heart attack patients. It fits
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, thus
reducing the risk of malapposition and complications associated with
conventional stents in this setting.

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 the 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 as
cardiac death, target vessel re-MI, emergent by-pass, 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 MACE rate at
30 days was 3.5% for the full study population and 2.5% when post-dilation was
performed. Mortality rate at 30 days was 1.2% for the full study population.
An interim analysis conducted on the first 600 patients at the one-year time
point showed a death rate of 1.7% where conventional stents average 3.9%
(pooled analysis from ACTION Study Group, Prof. G. Montalescot at
Pitié-Salpêtrière Hospital).

About the APPOSITION V Study
APPOSITION V is a prospective, multi-center, randomized, two-arm clinical
trial to evaluate the safety and effectiveness of the STENTYS
Self-Apposing®Stent in the treatment ofde novostenotic lesions in coronary
arteries in 880 patients undergoing primary revascularization due to
ST-elevation myocardial infarction (STEMI) as compared to the Multi-Link
Vision™ coronary system (Abbott Vascular, Inc.). The trial’s primary endpoint
is target vessel failure (TVF), which is defined as a composite of cardiac
death, target vessel recurrent myocardial infarction or clinically driven
target vessel revascularization (TVR) at 12 months post-procedure. The powered
secondary endpoint is acute stent malapposition and will be assessed by
intravascular ultrasound (IVUS) on the first 225 patients. All patients will
undergo clinical follow up at 30 days, six months, nine months and 12 months,
with an annual checkup through three years. Fifty sites are expected to
participate in the U.S. and worldwide. Enrollment is expected to begin in H1
2013.

About STENTYS
STENTYS is developing and commercializing innovative solutions for the
treatment of patients with acute myocardial infarction (AMI, or heart attack)
and complex coronary artery disease. STENTYS’s Self-Apposing^® Stents are
designed to adapt to vessels with ambiguous or fluctuating diameters,
particularly in the post-infarction phase, in order to prevent the
malapposition problems associated with conventional stents. In the APPOSITION
III clinical trial, STENTYS stents demonstrated a very low 30-day mortality
rate among 1,000 high-risk AMI patients when compared to recent studies with
conventional stents. More information is available at www.stentys.com.

STENTYS is listed on Comp. C of the NYSE Euronext Paris

ISIN: FR0010949404 – Ticker: STNT

Contact:

STENTYS
Stanislas Piot, +33 (0)1 44 53 99 42
CFO
stan.p@stentys.com
or
Europe: NewCap.
Axelle Vuillermet / Pierre Laurent, +33 (0)1 44 71 94 93
stentys@newcap.fr
or
US: MacDougall Biomedical Communications
Kari Watson, +1 781 235 3060
Christine Labaree, +1 650 339 7533
stentys@macbiocom.com
 
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