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Cardima’s Revelation: AF Self-Monitoring, Hazy Endpoints Hamper Review

This article was originally published in The Gray Sheet

Executive Summary

The ability of self-reporting to accurately track reduction in atrial fibrillation burden is cast into doubt by FDA panel experience with Cardima's Revelation ablation system data submission

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FDA Dispute Panel Rebuffs Cardima’s Catheter A-Fib Claims

An FDA dispute resolution body all but halted Cardima's chances to turn around the fortunes of its Revelation Tx microcatheter NavAblator ablation system April 19, voting 5-0 not to recommend approval of the product

FDA Dispute Panel Rebuffs Cardima’s Catheter A-Fib Claims

An FDA dispute resolution body all but halted Cardima's chances to turn around the fortunes of its Revelation Tx microcatheter NavAblator ablation system April 19, voting 5-0 not to recommend approval of the product

Cardima dispute headed to panel

FDA's Medical Device Dispute Resolution Panel will convene April 19 in Gaithersburg, Md., to hear Cardima's arguments for PMA approval of its Revelation Tx atrial fibrillation device. An advisory panel voted unanimously to reject the application in 2003, citing study design problems (1"The Gray Sheet" June 2, 2003, p. 3). A dispute is eligible for review by the panel only if the matter is based on "sound scientific grounds," and if "sufficient effort" has been made to resolve the complaint through less formal mechanisms...

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