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Neovasc Plans Next Steps After Thumbs Down From FDA Panel

 
• By Elizabeth Orr

FDA advisory committee members said the trial population was too small and homogenous and did not establish that Neovasc’s Reducer effectively treats angina.

Human heart. 3d illustration.

Canadian device firm Neovasc Inc. is still pondering its next steps after a US Food and Drug Administration advisory panel declined to endorse the company’s Reducer to treat angina in certain patients earlier this week.

The Circulatory System Devices Advisory Panel voted 14 to 4 that the device was safe, but only one of the 18 panelists thought its effectiveness had been established. The panel...

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