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The Neurological Devices Panel (the Panel) met on Thursday, May 11, 2000 to make recommendations to the Food and Drug Administration (FDA) on the approvability of the Cordis Endovascular Systems’, Inc.’s PMA for Trufill n-Butyl Cyanoacrylate (n-BCA) and Tantalum Powder intended for pre-surgical treatment of arteriovenous malformations (AVMs). AVMs are a relatively rare cerebrovascular disease having an incidence of only 2500 new cases diagnosed in the US every year, and there is great individual heterogeneity of AVMs among these cases.
The sponsor presented its information on the safety and effectiveness of the device, and FDA reviewers summarized the agency’s concerns about the PMA. Three Panel members, a biochemist, an interventional radiologist, and a statistician then gave their perspectives on device. After deliberations on the information in the submission, the Panel considered FDA’s questions.
The Panel voted four to two to recommend that FDA approve the PMA with conditions. Two conditions of approval are inclusion of statements in the labeling that the long-term safety of the device is not established and that the amount of n-BCA used in the study patients ranged from 10 to 70 percent. A third condition was that a training program be established. The last condition of approval was that the sponsor’s currently ongoing pre-clinical study with the three component mixture be completed and submitted for FDA review with the assumption that the study results would be similar as those for the uncombined individual three components of the device mixture.
The Panel membership for this meeting consisted of two neurosurgeons, two interventional radiologists, a biomedical engineer, a biochemist, a statistician, a consumer representative, and an industry representative.
Contact: Janet L. Scudiero, Executive Secretary, at 301-594-1184 ext. 176 or email@example.com.
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