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FDA panel recommends approval of hip resurfacing device

The advisory panel made the recommendation on the condition that manufacturer Smith & Nephew perform a 10 year postmarket study.

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The Birmingham Hip Resurfacing system (Smith & Nephew) is the first device of its kind in the United States, incorporating a resurfacing femoral component and metal-on-metal articulating surfaces. COURTESY SMITH & NEPHEW

The Orthopedic and Rehabilitation Devices advisory committee to the FDA voted 4-to-2 Sept. 8 to recommend approval of the Birmingham Hip Resurfacing System, a metal-on-metal prosthesis. The panel conditioned approval upon manufacturer Smith & Nephew conducting a 10-year clinical and radiographic follow-up study based on “sound statistical principles.”

Some panel members voiced general satisfaction with the device’s efficacy and safety. However, other members expressed concern about the size and scope of the patient cohort used in an uncontrolled study, as well as concern over safety data and the learning curve required for proper use.

The Birmingham Hip Resurfacing (BHR) system is the first device of its kind in the United States, according to John S. Goode, the FDA’s chief reviewer for Smith & Nephew’s application. The BHR implant is the first total hip replacement (THR) system with a resurfacing femoral component and metal-on-metal articulating surfaces, he said.

The BHR has a stemmed femoral head designed for cemented fixation and a hemispherical acetabular cup designed for cementless fixation. Both the femoral head and cup are made of high carbon cobalt-chrome, according to the Smith & Nephew literature.

The company designed the BHR implant for patients undergoing THR to relieve pain and improve function due to non-inflammatory degenerative joint diseases such as osteoarthritis. The implant is also designed for patients with inflammatory degenerative joint diseases such as rheumatoid arthritis, according to Derek J.W. McMinn, FRCS, an orthopedic surgeon from Birmingham, England. McMinn has implanted 2385 BHRs between July 1997 and May 2004.

Approvable letter received

Biomet Inc. also announced that the FDA has issued an approvable letter for the company's C2a-Taper Acetabular System. The company expects to initiate U.S. rollout of the product immediately following receipt of a final approval order, which it expects to receive by the end of the year.

The C2a-Taper system is a ceramic-on-ceramic hip replacement prosthesis featuring Biomet’s Porous Plasma Spray technology. Similar to other ceramic-on-ceramic prostheses, the source of the C2a-Taper Acetabular System's ceramic head and ceramic liner is CeramTec AG.

Biomet has sufficient inventory to immediately complete the U.S. product launch upon completion of the regulatory approval, company officials said in a press release.