Circulatory System Devices Panel Meeting Summary for February 5, 2001
A meeting of the Circulatory System Devices Panel was held on February 5, 2001. In the morning, the panel discussed and made recommendations on a premarket notification submission, K003992, for the Percusurge Guardwire Plus® Temporary Occlusion and Aspiration System. The Panel heard a presentation by Percusurge on the results of the Safer Trial, the primary clinical study used to support the safety and effectiveness of the device. The study was a prospective, multicenter, randomized clinical study of 801 patients needing treatment of occlusions of a saphenous vein graft to a coronary artery. Of these, 659 were enrolled with the inclusion criteria of diffuse disease. Three hundred thirty four of these patients were randomized to receive treatment with the Guardwire device, and 325 did not receive treatment with the device. The primary effectiveness endpoints were the degree of technical and procedural success. The primary safety endpoint was the rate of major adverse cardiac events (MACE). Following a presentation by the FDA, the Panel discussed the application and addressed the FDA’s questions. The Panel was not asked to vote on the application, but felt that the benefits of the product outweighed the risks.
In the afternoon, the Panel was asked to discuss clinical study design issues for distal protection devices used in the treatment of saphenous vein graft disease. The Panel heard presentations by members of the audience representing industry, academia, and clinicians. Following this discussion, the Panel addressed questions posed by the FDA.
This was followed by a closed session in which the Panel heard confidential and trade secret information.
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