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), today presented final
results from the APPOSITION IV study of its new Self-Apposing
sirolimus-eluting stent (SES) during the Hotline session at the EuroPCR
conference in Paris.
APPOSITION IV enrolled 152 patients experiencing ST-elevation myocardial
infarction (STEMI) and was the first clinical trial to evaluate the
novel Self-Apposing sirolimus-eluting stent, which was compared to
Medtronic’s Resolute® zotarolimus-eluting stent at two
different time points, 4 and 9 months. The evaluation was based on two
imaging modalities: Quantitative Coronary Angiography (QCA) to measure
the difference in artery diameters between implantation and follow-up,
and Optical Coherence Tomography (OCT) to quantify the number of stent
struts apposed and “covered” by tissue, an indication that the
endothelial cells lining the artery wall have grown around the stent and
that the vessel has healed.
At 9 months, the STENTYS SES showed no reduction in artery lumen
diameter (Late Lumen Loss of 0.04mm ± 0.43 under QCA) with a near
perfect arterial healing (99% covered struts at 9 months under OCT),
demonstrating stent efficacy and safety.
Stent apposition was statistically better in the STENTYS group than the
balloon-expandable group at 4 months (0.07% malapposed struts vs 1.16%,
p=0.005), and a greater percentage of STENTYS stents were fully covered
(33% vs 4%, p=0.02). At 9 months, strut apposition and coverage were
similar in both groups. The results confirm that arteries with STENTYS
SES healed faster than with balloon-expandable drug-eluting stents.
"In the APPOSITION IV trial, we found that the addition of sirolimus
elution to the STENTYS platform brings the best of both worlds together
for heart attack patients,” said Robert-Jan van Geuns, M.D., Ph.D.,
Erasmus Medical Center (Rotterdam, the Netherlands), co-Principal
investigator. ”An efficacious drug with a perfectly apposed stent
over time ensures fast healing and an open vessel in the long run."
"We are thrilled with the results and very grateful to the APPOSITION
IV study investigators for further advancing the knowledge and clinical
experience of the Self-Apposing technology," said Gonzague
Issenmann, CEO and co-founder of STENTYS. "With these study results,
our sirolimus-eluting stent could receive CE Mark as soon as the second
half of this year."
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 or patients with atypical artery anatomy. Its flexible,
self expanding design takes the shape of the patient’s unique vessel
anatomy and apposes to the irregular contours of a blood vessel, in
particular after an AMI as the vessel dilates and the clot dissolves. It
reduces the risk of malapposition and complications associated with
conventional stents in this setting. The STENTYS Self-Apposing Stent has
been marketed in Europe since receiving CE Mark in 2010. The STENTYS
Sirolimus-eluting stent should receive the CE Mark during the second
half of 2014.
About the APPOSITION IV Study
APPOSITION IV is a prospective, randomized, four-arm, multi-center study
designed to compare the STENTYS Sirolimus eluting stent (90 patients)
with Medtronic Resolute® (62 patients) in the treatment of
ST-elevation Myocardial Infarction. Patients were followed up at either
4 months (63 patients) or 9 months (89 patients). The endpoints are
strut apposition and coverage under OCT at 4 and 9 months.
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’ 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 one year 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.
This press release contains forward looking statements about the
Company’s business. Such forward looking statements are based on
numerous assumptions regarding the Company’s present and future business
strategies and the environment in which it will operate in the future
which may not be accurate. Such forward-looking statements involve known
and unknown risks which may cause the Company’s actual results,
performance or achievements to differ materially from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Such factors include, among others, risks
associated with the development and commercialization of the Company’s
products, market acceptance of the Company’s products, its ability to
manage growth, the competitive environment in relation to its business
area and markets, its ability to enforce and protect its patents and
proprietary rights, uncertainties related to the U.S. FDA approval
process, including with respect to a pre-market approval for the
Company’s BMS, slower than expected rates of patient recruitment for
clinical trials, the outcome of clinical trials, and other factors,
including those described in the Section 4 “Risk Factors” of the
Company’s 2011 Registration Document (document de référence)
filed with the French Autorité des Marchés Financiers on August
27, 2013 under number R.13-040 as such section may be updated from time
to time.
STENTYS is listed on Comp. B of the NYSE Euronext Paris
ISIN:
FR0010949404 – Ticker: STNT
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