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Chilli RF Ablation System Approval Broader Than Recommended By Panel

This article was originally published in The Gray Sheet

Executive Summary

Cardiac Pathways Corporation's Chilli cooled ablation system, approved via premarket approval application Feb. 2, has received a much less restrictive indication from FDA than recommended by the agency's Circulatory System Devices Advisory Panel.

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Cardiac Pathways

Ultrasound Tracking System computer system and catheters are expected to gain 510(k) clearance in late January-early February and March, respectively, the firm announces at AHA Nov. 8. The submissions were made in August. The system uses ultrasound transducers "to precisely triangulate, in real time, the position of the catheters within the heart during the diagnostic procedure," without the use of fluoroscopy, Cardiac Pathways explains. The firm plans to integrate the Tracking System with its Chilli cooled radiofrequency ablation catheter which received FDA premarket approval on Feb. 2 (1"The Gray Sheet" Feb. 8, p. 11)

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