A meeting of the Circulatory System Devices Panel was held on September 9-10, 2002. On September 9, the Panel discussed, made recommendations, and voted on a premarket approval application for W.L. Gore and Associates Excluder™ Bifurcated Endoprosthesis (P020004). The device is an endovascular graft placed percutaneously to treat infrarenal abdominal aortic aneurysms. Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (10-1) that the application be found ‘approvable with conditions’. The Panel’s conditions included recommendations for five year follow-up of the pivotal study cohort, submission of additional CT scan data and revisions to the labeling.
On September 10, the Panel discussed, made recommendations, and voted on a supplement to a premarket approval application for NMT Medical’s CardioSEAL® StarFlex Septal Occlusion System with QwikLoad™ (P000049/S3). The device is a double disk occluder indicated for closure of patent foramen ovale (PFO) in patients at risk for recurrent cryptogenic stroke or transient ischemic attack (TIA). Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (12-0) that the application be found ‘not approvable’ citing concerns over device safety and efficacy. The Panel recommended the company conduct a randomized controlled trial to demonstrate that the device is superior to medical therapy in preventing cryptogenic strokes in patients with PFO.
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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.