FDA
11th March 2015

FDA Panel Supports Approval of Radiesse for Hand Augmentation

Radiesse is an injectable filler (Merz North America, Inc) for hand augmentation. It is a synthetic calcium hydroxylapatite approved that was approved in 2001 in the US. Radiesse is currently approved.

FDA Panel Supports Approval of Radiesse for Hand Augmentation

On February 27th, the FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted 9 to 4 that the benefits of Radiesse outweigh its risk. The majority of panelists also voted that it was safe and effective.

Radiesse is an injectable filler (Merz North America, Inc) for hand augmentation. It is a synthetic calcium hydroxylapatite approved that was approved in 2001 in the US. Radiesse is currently approved for several indications such as nasolabial folds in 2006, and has been used off-label for hand augmentation — and is approved in 52 countries for that indication. The makers of Radiesse suggest that FDA approval of Radiesse for hand augmentation would ensure proper training and use.

Merz submitted data from one pivotal randomized controlled study of 114 patients at six US sites. Eighty-five patients were randomly assigned to immediate treatment and 29 to delayed treatment and were considered controls. The control group crossed over to treatment at 12 weeks. All patients were eligible for retreatment at 24 weeks. There were live hand evaluations at baseline, 12, 24, 36, and 48 weeks. Photographs were also taken, but the live evaluations were given the most weight.

According to Merz, 75% of Radiesse patients had at least a one point improvement at three months compared with 3% of those in the control group. The mean change in the MHGS from baseline was 1.1 point for those given Radiesse compared with 0.1 in the control group.

Nonetheless, the panel expressed some concern about the variability of the efficacy results. In addition, the panel expressed some concern regarding long-term safety, and asked the FDA to require postmarketing studies that would assess radiographic evidence of implant stability and also of impact on hand function.

Panel member Glenn B. Pfeffer, MD, director of the foot and ankle program at Cedars-Sinai in Los Angeles, California noted, “With FDA oversight of this product, it will be safer for the public.”

The FDA is not obligated to follow the advice of its advisory committee panels, but normally does so.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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