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FDA panel to rate cooling catheter

This article was originally published in The Gray Sheet

Executive Summary

Circulatory System Devices Panel convenes March 17 in Gaithersburg, Md. to review a 510(k) submission for a device applying mild hypothermia to treat patients rendered unconscious by cardiac arrest. Alsius' CoolGard system, which uses a proprietary catheter to fill two MicroTherm cooling balloons in the superior vena cava, currently lacks the indication under review. [Editor's note: To order a webcast or DVD of the panel meeting, visit "The Gray Sheet" affiliate] Radiant Medical markets Reprieve, a second-gen version of the SetPoint endovascular temperature management system, cleared in 2002 for "cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care." Panelists agreed last September that safety studies are needed to assess hypothermia as therapy for comatose patients after cardiac arrest (2"The Gray Sheet" Sept. 27, 2004, p. 5)...

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