FDA panel rejects Medtronic's AF ablation system on safety; path clear for Atricure
This article was originally published in Clinica
Executive Summary
An FDA advisory panel has voted against approval of Medtronic's phased radiofrequency (RF) ablation system for the treatment of persistent atrial fibrillation (AF) because of safety concerns. The decision clears the way for rival product, AtriCure's Synergy system, to become the first ablation device to be FDA approved for persistent AF.