FDA Advisory Committee Shoots Down Neovasc’s Reducer Stent

November 10, 2020

An FDA advisory committee has recommended that the agency not grant approval for Canadian devicemaker Neovasc’s Reducer System to treat angina.

The Circulatory Devices Panel for the agency’s Medical Devices Advisory Committee voted 17-1 in an Oct. 27 meeting that the system is not effective for use in refractory angina patients who are unsuitable for revascularization by coronary artery bypass graft surgery or percutaneous coronary intervention.

In a separate 13-3 vote, with two abstentions, the expert panel also concluded that the risks of the Neovasc Reducer System outweigh the benefits for those patients.

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