23.02.2015 17:45:00
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Results of Largest STENTYS Stent Trial in Myocardial Infarction Published in EuroIntervention
Regulatory News:
STENTYS (Paris:STNT) (FR0010949404 — STNT), a medical technology company commercializing the world's first and only Self-Apposing® coronary stent, today announced that the one-year clinical outcomes of the APPOSITION III registry (see the press release from March 9, 2013), which studied the STENTYS Self-Apposing coronary stent in patients presenting with ST-segment elevation myocardial infarction (STEMI), have been published in EuroIntervention, the official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).
The clinical study showed that the use of the STENTYS Self-Apposing stent in the setting of primary PCI was feasible and associated with low cardiovascular event rates. The publication can be found at: http://www.pcronline.com/eurointervention/ahead_of_print/201502-08/
Gonzague Issenmann, co-founder and Chief Executive Officer of STENTYS commented: "These favorable results highlighted in EuroIntervention, one of the most read peer-reviewed journal of the interventional cardiology community, draw attention to the excellent safety profile of the Self-Apposing stents.” He added: "We look forward to advancing the adoption of the STENTYS technology among cardiologists to the benefit of heart attack patients worldwide.”
About the APPOSITION III Trial
The APPOSITION III trial is a
prospective, single-arm, multi-center study designed to assess the long
term performance of STENTYS Self-Apposing Stents in routine clinical
practice in Europe among patients suffering from ST-elevation myocardial
infarction (STEMI). The primary endpoint, Major Adverse Cardiac Events
rate (MACE, defined as cardiac death, target vessel re-MI, emergent
by-pass, or clinically driven TVR) at one year, was 9.3%, where
conventional stents average 11.1% in a pooled analysis from ACTION Study
Group (Pitié- Salpêtrière Hospital, Paris). At the one-year time point,
the cardiac death rate was 2.0%, compared with rates for conventional
stents in other published trials which average 3.9% .
About STENTYS
STENTYS is developing and commercializing
innovative solutions for the treatment of patients with complex artery
disease. STENTYS’ Self-Apposing® drug-eluting stents are
designed to adapt to vessels with ambiguous or fluctuating diameters in
order to prevent the malapposition problems associated with conventional
stents. The APPOSITION clinical trials in the treatment of acute
myocardial infarction showed a very low one year mortality rate and a
faster arterial healing compared to conventional stents. The company’s
product portfolio also includes MiStent SES®, a coronary DES
whose new drug delivery mechanism is designed to match vessel response,
and is marketed through STENTYS’ commercial network in Europe, the
Middle East, Asia and Latin America. More information is available
at www.stentys.com.
Safe Harbor Statements
This press release contains
forward-looking statements about the Company that 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, 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 2013
Registration Document (document de référence) filed with the French
Autorité des Marchés Financiers on October 29, 2014 under number
D.14-1026 as such section may be updated from time to time.
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