Stentys granted EU approval for stent

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Stentys has received CE marking for its self-expanding and disconnectable stent to treat acute coronary syndrome.

The self-expanding feature of the Stentys platform is designed for apposition of a stent in the initial hours and days after an acute MI procedure, according to the Paris-based company, by “being continuously applied to the vessel’s internal surface.”

Stentys said it is planning to expand clinical evaluation with its randomized APPOSITION II trial, which compared the Stentys self-expanding stent with a conventional balloon-expandable stent in acute MI patients, using optical coherence tomography imaging to validate endpoints.