A meeting of the Circulatory System Devices Panel was held on October 2, 2003. The Panel discussed, made recommendations, and voted on a premarket approval application supplement (P910001/S22) for the Spectranetics CVX-300 Excimer Laser System.
The device is indicated for facilitation of limb salvage in patients with critical limb ischemia (associated with Rutherford Categories 4,5, and 6) who have angiographically evident culprit stenoses and/or occlusions in the SFA, popliteal and/or infrapopliteal arteries, who are poor surgical candidates, and who are acceptable candidates for revascularization.
Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (9-1) that the application be found ‘not approvable’. The Panel cited concerns with the choice of a control group for the study and data insufficient to support the effectiveness of the device.
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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.