On October 19, 2000, the Gastroenterology and Urology Devices Advisory Panel met to make recommendations on P000029, Deflux Injectable Gel from Q-Med AB for the treatment of vesicoureteral reflux in children. This device is an injectable bulking agent comprised of particles of crosslinked dextran in a solution of hyaluronic acid, which is injected into the bladder submucosa adjacent to the ureteral orifice to block the flow of refluxing urine. The Panel voted 4 to 2 in favor of a recommendation to approve the PMA with three conditions. The conditions outlined by the Panel were: (1) revision of the labeling to include certain additional information regarding indications, contraindications, warnings, precautions, study data, and patient follow-up and counseling; (2) collect and analyze the available long-term safety and effectiveness data on existing study patients; and (3) perform a postapproval study at multiple U.S. centers to confirm the safety and effectiveness of Deflux in relevant subsets of patients (i.e., stratified by age, gender, baseline reflux grade, number of retreatments, and race).
Contact: Jeff Cooper, Executive Secretary, at 301-594-1220, x122
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