A meeting of the Circulatory System Devices Panel was held on April 21, 2004. The Panel discussed, made recommendations, and voted on a premarket approval application supplement (P030047) for the Cordis Corporation, Cordis Precise Nitinol Stent System.
The device is indicated for use in the treatment of carotid artery disease in high-risk patients.
The Panel voted (6-5) that the application be found ‘approvable with conditions’. The Panel’s conditions included modifying the indication for use to treatment of patients needing carotid revascularization and having specific anatomic or medical comorbid conditions (to be indicated in the labeling). The Panel’s conditions included adding a warning to the labeling regarding the potential for increased risk of adverse events if the user is unable to deploy the Angioguard Emboli Capture Guidewire. The Panel also recommended the patient labeling be modified to include specific comments noted during the discussion period and that the post-marketing study be modified to stipulate evaluation by an independent neurologist for the 30-day exam in the 1000 patients enrolled post-market, and at the annual exams for the patients currently enrolled in the IDE 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.