FDA Panel Votes Against Cardima’s A-Fib Device
April 23, 2007 — The FDA’s Medical Device Dispute Resolution Panel decided late last week to recommend against approval of Cardima’s REVELATION Tx Microcatheter System, a device designed to treat atrial fibrillation. In a written release Friday, the company said the panel had commented favorably on the need for this type of device but believed that efficacy data was not sufficiently clear and supportive for approval.
The REVELATION Tx system is a minimally invasive, single-use, microcatheter-based product designed to provide easy access to arrhythmia-causing tissue, creating linear lesions or restricted pathways, and restoring normal sinus rhythm to the heart using radiofrequency (RF) energy.
Disappointed in the panel outcome, Cardima CEO Gabe Vegh said the company is considering its options in the U.S., but meanwhile will continue marketing its next generation ablation EP systems, which include the REVELATION T-Flex and the INTELLITEMP, in the European Union and the rest of the world where it is licensed to promote and sell these products.
For more information visit www.cardima.com.