Experts urge flexibility over heart device studies

09/21/2007 | NYTimes.com

A panel of experts advised the FDA to be flexible on restrictions overseeing the clinical trials of devices for the treatment of atrial fibrillation. Manufacturers and doctors say patient enrollment in clinical studies is difficult because some patients that want ablation are unwilling to be assigned to groups that receive arrhythmia drugs instead. The advisory panel hearing also tackled the challenges faced in data gathering and interpretation of trial results.

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