A meeting of the Circulatory System Devices Panel was held on April 22, 2005, at the Holiday Inn located at Two Montgomery Village Avenue in Gaithersburg, Maryland. The meeting opened with a presentation by Susan Gardner, PhD, Director, Office of Surveillance and Biometrics, CDRH, describing recent changes in CDRH regarding Condition of Approval Studies. David Buckles, PhD, FACC, Branch Chief of the Peripheral Vascular Devices Branch of the Division of Cardiovascular Devices presented an update to the panel regarding a device brought before this panel on January 13, 2005. Dr. Buckles discussed the March 23, 2005 approval of the Gore Thoracic Aortic Aneurysm Stent-Graft (Gore TAG) Device intended for endovascular repair of aneurysms of the descending thoracic aorta and conditions of approval required for this device.
The Panel discussed a 510(k) application for the Cardica™ PAS-Port™ System. The Cardica™ PAS-Port™ System is intended to create an everting anastomosis (end-to-side) between the aorta and autologous vein graft.
Following presentations by the sponsor and the FDA, and after questioning the sponsor and discussion, the general consensus of the panel was that the available clinical data for this device does not provide an overall risk/benefit ratio which supports marketing clearance of the device in the United States for the proposed indication. The panel expressed a need for more clinical data to support the safety and effectiveness of the device. The panel also suggested the intended use should reflect the population the study used for the study.
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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.