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Stentys Receives FDA Approval to Initiate First U.S. Clinical Trial With Self-Apposing® Stent


10/22/2012 11:15:56 AM

PRINCETON, N.J. & PARIS--(BUSINESS WIRE)--STENTYS (FR0010949404 – STNT), a medical technology company that is commercializing in Europe the world's first and only Self-Apposing® stent to treat acute myocardial infarction (AMI), announced today that it has received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to conduct a pivotal clinical trial in the United States which, if successfully completed, will enable the Company to apply for marketing approval of the STENTYS Self-Apposing stent.

Read at BioSpace.com

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