Neovasc Submits Premarket Approval Application to FDA for Neovasc Reducer™
Neovasc Inc. - Common Shares (NVCN)
Last neovasc inc. - common shares earnings: 3/30 04:08 pm
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Source: GlobeNewswire
VANCOUVER, Dec. 31, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today announced the submission of a Premarket Approval application (“PMA”) to the U.S. Food and Drug Administration (“FDA”) for its Neovasc Reducer™ (“Reducer”) medical device for the treatment of refractory angina. The submission also includes a request for an Advisory Panel meeting. “This submission marks an important milestone in our effort to bring Reducer to the U.S. market, where it is estimated that there are up to 1.8 million patients with refractory angina,” said Fred Colen, President and Chief Executive Officer of Neovasc. “These patients have traditionally had no options – they are either unsuitable for revascularization or continue to suffer with ang
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