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US to explore registry to support innovation in device-based therapy for atrial fibrillation

This article was originally published in RAJ Devices

Executive Summary

The US Food and Drug Administration is to host a think-tank meeting in April to explore whether setting up a national registry of atrial fibrillation ablation procedures and outcomes would help support, among other things, the development of medical technology for this condition1. The agency describes atrial fibrillation as a major public health problem in the US. New medical devices to image, map and systematically ablate the atria have shown promise for the restoration of sinus rhythm, but, says the FDA, the optimal technique, short- and long-term safety and durability of methods and adjunctive medical therapy, all remain “areas of concern”.

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