The General and Plastic Surgery Devices Advisory Panel met on August 24 & 25, 2006 at the Holiday Inn located at Two Montgomery Village Avenue in Gaithersburg, Maryland. The panel met in order to provide advice and recommendations to the Agency for 2 premarket approval applications for BioForm Medical Inc.’s Radiesse Dermal Filler indicated for facial treatment of HIV associated lipoatrophy and for treatment of moderate to severe wrinkles such as nasolabial folds, respectively. Radiesse is an injectable dermal filler featuring calcium hydroxyapatite microspheres.
The meeting began on August 24 with CAPT Stephen P. Rhodes (Branch Chief, Plastic and Reconstructive Surgery Branch) giving the panel an update since the last panel meeting. CAPT Rhodes presentation was followed by BioForm Medical Inc.’s presentation of their clinical data from their treatment of HIV associated lipoatrophy study. With respect to the clinical trial data, both the sponsor and the FDA focused their presentations on the clinical data provided. The study was on open label, multicenter, non-randomized, non-comparator study intended to assess the safety and effectiveness of the device for soft tissue augmentation for the treatment of facial lipoatrophy. The study assessed the correction of HIV-associated facial lipoatrophy 3 months after the final treatment by comparing changes from baseline on the Global Aesthetic Improvement Scale. Safety was assessed by recording the incidence, severity, and duration of all local and systemic adverse events through 12 months.
The study enrolled 100 patients with a mean age of 48.2 years (94% males). All assessed patients exhibited improvement over baseline at 3 months. The panel engaged in an in-depth discussion of the PMA data and the FDA questions. The BioForm PMA for Radiesse to be used for the treatment of HIV-associated lipoatrophy (P050037) was recommended as “approvable with conditions” by a 5 to 2 vote. Among the conditions were training for physicians, 18-month post approval study and in inclusion of a precaution in the labeling that the device has only been tested in HIV-lipoatrophy patients.
The second PMA for BioForm’s Radiesse (P050052) was discussed in the afternoon session. This study was a prospective, randomized, controlled trial for the use of Radiesse for the treatment of stage 3 or 4 nasolabial folds (on a 0 to 5 scale). The trial assessed the patients at 3 and 6 months after optimal correction was achieved. In this study, 117 patients received treatment, 115 were available for the primary effectiveness measurements at 3 months and 113 at 6 months. The safety analysis was performed on all 117 patients of whom 113 were available at 6 months. The mean age of enrolled patients was 54.7 years (89.7% female). Safety results were determined to be equivalent for Radiesse and the control treatment (a human collagen implant) at all time points.
Radiesse was shown to be non-inferior to control at 3 months. A subsequent superiority assessment confirmed that Radiesse was superior to the control at 3 months in 84.6% (99/117) of evaluations. A superior determination was based on a greater than 1-point improvement over the comparative treatment. The panel recommended Radiesse for treatment of nasolabial folds for “approvable with conditions” by a 5 to 2 vote. The conditions included a post-approval study to assess the duration of effect, timing of repeat treatments and the long-term safety of Radiesse treatment, a second post-approval study to gain additional safety data in people of color who are more likely to develop keloid or hypertrophic scarring, that the labeling include a precaution that Radiesse has not been adequately studied in people of color and that their be physician training.
On August 25, 2006 the panel meeting continued with presentations regarding the petition proposing reclassification of the cyanoacrylate tissues adhesives for the topical approximation of skin. The panel heard presentations from the petitioner, the Regulatory & Clinical Research Institute, Inc., the FDA, and from two manufacturers of cyanoacrylate tissue adhesives, United States Surgical (Division of Tyco Healthcare Group LP) and Closure Medical Corporation. The panel discussed the information, filled out the FDA questionnaires and unanimously voted to recommend that the cyanoacrylate tissue adhesives for the topical approximation of skin be reclassified from Class III to non-exempt Class II with a guidance document as the special control. The major risk identified by the panel was the possibility of dehiscence.
Contact: David Krause, Ph.D., Executive Secretary, 301-594-3090, x141
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