A meeting of the Medical Devices Dispute Resolution Panel was held on December 15, 2006. The Panel was convened to hear a scientific dispute between FDA and Acorn Cardiovascular, Inc. (Acorn) related to the approvability of a premarket approval application (PMA) for the CorCap® Cardiac Support Device (CSD) (P040049) for patients with dilated cardiomyopathy. The Panel discussed, made recommendations, and voted regarding the approvability of a premarket approval application for the CorCap® CSD (P040049), as amended.
The CorCap® CSD , manufactured by Acorn Cardiovascular, Inc., is a non-resorbable polyester mesh implanted around the heart to provide ventricular support and reduce ventricular wall stress. The CorCap® CSD is indicated for use in adult patients who have been diagnosed with dilated cardiomyopathy; are symptomatic despite treatment with optimal heart failure medical management; have a dilated heart (indexed left ventricular enddiastolic dimension (LVEDDi) > 30 and < 40 mm/m2); and have an LVEF ≤ 35% (or LVEF < 45% if planned mitral valve repair or replacement).
On June 22, 2005, the Circulatory System Devices Panel reviewed the CorCap® CSD PMA P040049. The Circulatory Panel voted 9-4 for Not Approval of the device. On August 12, 2005 FDA issued Acorn a not approvable letter regarding its PMA P040049 for the CorCap® CSD. FDA issued a second not-approvable determination on February 2, 2006 for the amended PMA. On May 19, 2006 Acorn requested the review of this scientific dispute by the Medical Devices Dispute Resolution Panel. Acorn 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 July 7, 2006 the request for a review by the Medical Devices Dispute Resolution Panel was granted.
Following presentations by, and questions to, Acorn and FDA, the Panel voted 3-1 to recommend to the CDRH Director that the PMA, as amended, for CorCap® CSD (P040049) 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.