Healthcare Industry News: CoreValve
News Release - March 5, 2010
Stentys self-expanding stent receives CE Marking to treat acute coronary syndrome (ACS)PRINCETON, N.J. & PARIS--(HSMN NewsFeed)--Medical device pioneer Stentys announced today that it has received CE Marking for its self-expanding and disconnectable stent to treat acute coronary syndrome (ACS).
“For European regulatory approval we have demonstrated how the Stentys stent perfectly conforms to a variable vessel anatomy after AMI stenting,” said Gonzague Issenmann, CEO and co-founder of Stentys. “Our strategy is to expand clinical evaluation with our ‘APPOSITION II’ clinical study. This is a randomized trial comparing the Stentys self-expanding stent with a conventional balloon-expandable stent in AMI patients, using extremely high-resolution OCT (optical coherence tomography) imaging to validate endpoints.”
Based in Princeton, N.J., and Paris, Stentys intends to make treatment of complex blocked coronary arteries as simple and effective as a conventional stenting procedure. The Company announced in December 2009 that it has started enrolling patients in the randomized APPOSITION II clinical trial to compare the Stentys self-expanding stent against conventional stents in treating AMI patients, looking specifically at stent apposition and adaptation to vessel growth. Stentys was co-founded by Gonzague Issenmann and Jacques Séguin, M.D., Ph.D., founder of CoreValve, which was acquired last year by Medtronic for $700 million plus earn-outs.
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