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FDA Advisors Vote That Benefits Of Abbott’s MitraClip Outweigh Risks

This article was originally published in The Gray Sheet

Executive Summary

The agency’s Circulatory System Devices Panel narrowly voted in favor of Abbott’s MitraClip transcatheter mitral valve repair system to reduce mitral regurgitation. But the discussions about the clinical evidence on the technology were complex and the panel’s support for Abbott’s PMA was not unanimous.

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