One-year APPOSITION III results in 1,000 heart attack patients presented at ACC.13

PRINCETON, N.J. and PARIS – March 9, 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 one-year results of the APPOSITION III clinical trial in 1,000 patients post treatment of a severe heart attack at ACC.13, the American College of Cardiology’s Scientific Session & Expo.

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%, as compared with rates for conventional stents in other published trials which average 3.9%, the lowest rate being 2.2%.

“The very low rates of mortality (2.0%) and target-vessel re-infarction (1.3%) in the APPOSITION III study clearly highlight the excellent safety profile of Self-Apposing stents,” commented Prof. Gilles Montalescot, M.D., Ph.D., Head of the Cardiac Care Unit at Pitié-Salpêtrière Hospital and investigator of the study, who presents the data at the conference.

“The strong results reported today continue to suggest the superiority of the Self-Apposing Stent in the treatment of AMI,” said Gonzague Issenmann, CEO and co-founder of STENTYS. “We expect these data will contribute to the ongoing adoption of the technology among cardiologists in Europe and further support the initiation of our FDA-approved U.S. pivotal trial, APPOSITION V, during the first half of 2013.”

In its latest guidelines on AMI treatment, the European Society of Cardiology (ESC) calls attention to the importance of selecting the appropriate stent size. During a heart attack treatment procedure, the presence of a thrombus (clot) and the natural vessel contraction prevent cardiologists from determining the artery diameter with certainty. When selecting a conventional stent size, there is a risk of under sizing, causing malapposition, or oversizing, causing vessel wall injury; either leads to increased risk of heart attack recurrence. The STENTYS Self-Apposing Stent solves that “stent-sizing dilemma”: 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.