The Medical Devices Dispute Resolution Panel met on April 19, 2007 at the Holiday Inn in Gaithersburg, Maryland. The Panel was convened to hear a scientific dispute between FDA and Cardima, Inc. (Cardima) related to the approvability of a premarket approval application (PMA) for the REVELATION Tx Microcatheter Ablation System (P020039) for use in the treatment of atrial fibrillation (AF) in patients with drug refractory paroxysmal AF.
The REVELATION® Tx Microcatheter System consists of a single use, steerable, multi-electrode ablation microcatheter (3.7F) with an atraumatic, flexible, non-electrically active tip, and a single use, deflectable NAVABLATOR® “hot tip” ablation catheter (8F) with an electrically active tip. Accessories to the system include Cardima’s support catheter, NAVIPORT® (cleared under K974683), the Tx SELECT™ Switchbox and the associated connecting cables. The Phase III study protocol specified that the NavAblator catheter was optionally available for ablation of the isthmus after first attempting to create a linear burn with the REVELATION Tx.
On June 9, 2006 Cardima requested the review of this scientific dispute by the Medical Devices Dispute Resolution Panel. Cardima disagreed with ODE’s determination that the scientific data and information submitted with this PMA were not sufficient to support approval of the device. On June 30, 2006 the request for a review by the Medical Devices Dispute Resolution Panel was granted.
Following presentations by, and questions to, Cardima and FDA, the Panel voted 5-0 to recommend to the CDRH Director that the PMA, as amended, for the REVELATION® Tx Microcatheter System be not-approvable.
Nancy Collazo-Braier, Ph.D., Executive Secretary,
(240) 276-2939; Nancy.Braier@FDA.HHS.Gov
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Under normal circumstances, panel summary minutes are available 60-90 days post meeting. Summaries are also available on the CDRH web site.