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Safety Concerns Sink Medtronic A-Fib Catheter Ablation System At Panel

This article was originally published in The Gray Sheet

Executive Summary

Risks associated with Medtronic’s Phased RF catheter ablation system for atrial fibrillation outweigh the benefits of the device, FDA’s Circulatory System Devices panel concluded in an 8-2 vote on Oct. 27.

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