23.02.2015 17:45:00

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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