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In Brief: Cardima

This article was originally published in The Gray Sheet

Executive Summary

Cardima: Cardiovascular therapy firm commences multicenter, European trial of its Pathfinder minimally invasive microcatheter system for treatment of atrial fibrillation, the company reports. The microcatheter is currently approved in the U.S. for mapping atrial fibrillation and is sold under the tradename Revelation. The company plans to submit "within the next few months" an investigational device exemption with FDA for use of its Tracer VT over-the-wire microcatheter to perform ventricular tachycardia ablation. "The Gray Sheet" (Nov. 17, In Brief) incorrectly reported the company was seeking an IDE to conduct VT-ablation studies with its Revelation microcatheter. Cardima plans to file a separate IDE covering use of the Revelation for atrial fibrillation ablation...
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