After meeting with the FDA and “weighing all available options” Neovasc (NVCN) has decided to file a U.S. application for Neovasc Reducer by year-end.
It believes that data from the COSIRA trial, REDUCER-I European Post-Market study and multiple independent studies published in peer-reviewed journals should be sufficient to support a PMA application. It also intends to request an advisory committee meeting.
Reducer is a stent-like device used to treat refractory angina (chest pain caused by inadequate blood flow to the heart).
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