A meeting of the Circulatory System Devices Panel was held on November 20, 2003. The Panel discussed, made recommendations, and voted on a premarket approval application (P030025) for the Boston Scientific TAXUS™ Paclitaxel-Eluting Coronary Stent System.
The device is indicated for improving luminal diameter and reducing restenosis for the treatment of de novo lesions = 28 mm in length in native coronary artery = 2.5 to = 3.75 mm in diameter.
Following presentations by the sponsor and the FDA, and after questioning the sponsor and deliberating, the Panel voted (9-0) that the application be found ‘approvable with conditions’. The Panel recommended strengthening the labeling to state that the interaction between the drug-eluting stent and other drug-eluting stents has not been studied, add the maximum diameter to which the stent may be expanded to the labeling, correction of the patient numbers in the clinical data tables in the labeling, specify the stent used as the control in the clinical study within the indication statement and to specifically recommend the antiplatelet regimen of aspirin and clopidogrel or ticlopidine for 6 months.
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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,