Draft Guidance: Non-Randomized Trials OK For AFib Surgical Ablation Devices
This article was originally published in The Gray Sheet
Executive Summary
Studies other than randomized controlled trials can support approval for surgical ablation devices to treat atrial fibrillation, FDA affirms in a Sept. 14 1draft guidance
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FDA Panel Narrowly Endorses AtriCure’s Synergy For A-Fib Ablation
FDA’s Circulatory System Devices panel narrowly endorsed an expanded indication last week for AtriCure’s Synergy ablation system to treat certain types of atrial fibrillation during open-heart surgery, despite concerns over safety issues and limited data.