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FDA Panel Narrowly Favors Expanding Patient Population For Biventricular Pacing

This article was originally published in The Gray Sheet

Executive Summary

With the help of a tie-breaker vote, the Circulatory System Devices Panel said the benefits outweigh the risks of expanding the indications for biventricular cardiac resynchronization therapy devices to include patients at risk for developing new or worsened heart failure because of their need for right ventricular pacing. Medtronic is seeking the expansion in a submission before FDA.


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