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MEDTRONIC ATAKR RF ABLATION SYSTEM GETS PANEL NOD

This article was originally published in The Gray Sheet

Executive Summary

MEDTRONIC ATAKR RF ABLATION SYSTEM GETS PANEL NOD for the treatment of supraventricular tachycardias (SVT), including the treatment of certain asymptomatic patients. At a Dec. 5 meeting in Gaithersburg, Maryland, FDA's Circulatory Systems Devices Panel voted unanimously (6-0) to recommend approval of the device, which delivers radiofrequency energy via catheters to ablate cells within the heart muscle. The panel's recommendation would give the Atakr a slightly broader indication than the first commercially available RF ablation system, EP Technologies' RF Cardiac Ablation System, which was approved in October for treatment of SVT in symptomatic patients only ("The Gray Sheet" Nov. 7, p. 3).
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