Neovasc (NASDAQ:NVCN) announces its U.S. regulatory approval plan for Neovasc Reducer, a stent-like device used to treat refractory angina (chest pain caused by inadequate blood flow to the heart).
Per FDA guidance, it will pursue the Humanitarian Device Exemption (HDE) pathway for class IV angina patients (chest pain with any level of physical exertion), the quickest way to enable access for this population, while exploring an alternate clinical trial design aimed at broadening the patient population [class III (chest pain with mild exertion) and IV] and eliminating the restrictions associated with HDE status.
The Reducer is currently CE Mark certified.
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