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08.11.2011 18:20:00

Outstanding Interim Results of STENTYS International Clinical Study of 600 Heart Attack Patients

Regulatory News:

Lower rate of adverse events for STENTYS Self-Apposing™ Stent compared to reported results of conventional stents

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STENTYS S.A. (STNT.PA) (Paris:STNT), a medical technology company commercializing the world's first and only Self-Apposing™ Stent to treat Acute Myocardial Infarction (AMI), disclosed today data on 600 patients from its ongoing "APPOSITION III” international clinical study who underwent an examination 30 day after treatment of a severe heart attack.

"With only 2.4% of patients experiencing a Major Adverse Cardiac Event (MACE) at 30 days in the latest patient cohort compared to rates of over 5% in published landmark trials with conventional stents, these remarkable preliminary clinical results could challenge the existing gold standard of treating AMI patients with balloon-expandable stents,” said study investigator Dr. Robert Jan van Geuns, M.D., Ph.D., Thorax Center at Erasmus Medical Center, Rotterdam, the Netherlands.

"We believe that these impressive clinical results confirm the Self-Apposing™ technology as the best solution for treating heart attack patients, and will contribute to increase its adoption in routine practice,” said Gonzague Issenmann, CEO and co-founder of STENTYS.

The STENTYS Self-Apposing™ Stent represents a major breakthrough: it solves the stent sizing dilemma that cardiologists are confronted with when treating heart attack patients with conventional stents. It "fits snugly” into the contour of a blood vessel, and its shape and diameter adapt to the anatomic changes of the coronary arteries during the post-AMI phase, avoiding a major complication of all other conventional stents: malapposition.

Based in Princeton, N.J., and Paris, STENTYS has developed a new generation of stents to treat acute myocardial infarction (AMI). Founded by Jacques Séguin, M.D., Ph.D., (also founder of CoreValve, which was acquired by Medtronic) and Gonzague Issenmann, STENTYS received CE-marking for its flagship products in 2010. Its Self-Apposing™ stent adapt to the anatomic changes of the arteries in the post-infarction phase and thus prevents the malapposition problem associated with conventional stents. STENTYS has commenced marketing activities in several European countries.