STENTYS to Present Final Results From 1,000 Heart Attack
Patient Study at ACC.13.
Full
press release follows.
SOURCE:
STENTYS
02/26/2013|
12:40pm US/Eastern -- STENTYS to Present Final Results From 1,000 Heart Attack
Patient Study o. Educational
Symposium Also to Highlight FDA-Approved U.S. Pivotal Study for Self-Apposing®
Stent in STEMI Patients
PRINCETON,
N.J. and 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 of de novo stenotic 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
Stanislas
Piot, CFO
Tel.:
+33 (0)1 44 53 99 42
Europe:
NewCap.
Axelle
Vuillermet / Pierre Laurent Tel.: +33 (0)1 44 71 94 93 stentys@newcap.fr
STENTYS
is listed on Comp. C of the NYSE Euronext Paris
ISIN:
FR0010949404 - Ticker: STNT
US:
MacDougall Biomedical Communications
Kari
Watson, Tel.: +1 781 235 3060
Christine
Labaree, Tel.: +1 650 339 7533 stentys@macbiocom.com
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