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Further Data on Stentys Self-Apposing Stent Reinforces Strength of Clinical Results


5/23/2013 8:45:07 AM

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PRINCETON, N.J. & PARIS, May 22, 2013 (BUSINESS WIRE) -- STENTYS (FR0010949404 - STNT), a medical technology company commercializing in Europe the world's first and only Self-Apposing(R) Stent to treat acute myocardial infarction (AMI), announced today new one-year data from the APPOSITION III clinical trial at the international EuroPCR conference in Paris. APPOSITION III was designed to assess the long-term performance of STENTYS Self-Apposing Stents in routine clinical practice in Europe among 1,000 patients suffering a heart attack (ST-elevation myocardial infarction or STEMI).

The patient population was particularly high-risk since 70% of patients had completely occluded arteries (TIMI 0-1); the mean time from the onset of symptoms to treatment was 5 hours and 48 minutes. At one year, the mortality rate was 2.0%, re-infarction was 1.3% and the overall MACE rate (cardiac death, target vessel re-MI, emergent by-pass, or clinically-driven TVR) was 9.3%. Further analysis of data showed that the STENTYS Self-Apposing Stent performs equally well in many sub-groups: clinical outcome in female patients (23% of the population) was as good as in male (p=0.41), and diabetic patients (15% of the population) had similar clinical results as the rest of the population (p=0.85). Importantly, the first 5 patients treated in a center exhibited no statistically significant difference in MACE compared to patients treated onwards (p=0.65), indicating the absence of a learning curve in using the STENTYS Self-Apposing Stent.

"We continue to be encouraged by the excellent data produced to date for the STENTYS Self-Apposing Stent, including very low rates of death and re-infarction in STEMI patients," said Giovanni Amoroso, M.D., OLVG Hospital of Amsterdam and Principal Investigator of the study. "The drug-eluting version, which was selected by investigators for their higher risk patients, also showed very low rate of cardiac complications."

"The STENTYS Self-Apposing Stent is becoming an invaluable tool for cardiologists in Europe for treating patients with AMI," said Gonzague Issenmann, CEO and co-founder of STENTYS. "The additional clinical data will contribute to further adoption of our stent and to swift enrollment in the recently started APPOSITION V trial in the United States and worldwide."

About the STENTYS Self-Apposing(R) Stent

The STENTYS Self-Apposing(R) 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. The STENTYS Self-Apposing Stent has been marketed in Europe since receiving CE Mark in 2010.

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. The MACE rate at one year was 9.3% for the full study population, where conventional stents average 11.1%. Mortality rate at one year was 2.0%, where conventional stents average 3.9% (pooled analysis from ACTION Study Group, Prof. G. Montalescot at La Pitie-Salpetriere Hospital).



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