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FDA approves Smith & Nephew’s hip resurfacing system

Concerns over safety data and surgeon’s learning curve led to post-market study requirements.

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The FDA has cleared Smith & Nephew’s Orthopaedic Reconstruction division to market its Birmingham Hip Resurfacing system, making the device the only FDA-approved hip resurfacing system available in the United States, the company announced.

Hip resurfacing is sometimes an alternative to total hip replacement (THR) for treating hip abnormalities, including osteoarthritis, in patients who may not be suitable for traditional THR, such as younger, more active patients.

The Birmingham Hip Resurfacing (BHR) system, a metal-on-metal prosthesis, features a stemmed femoral head designed for cemented fixation and a cementless hemispherical acetabular cup design. Both components are made of high-carbon cobalt-chrome, according to Smith & Nephew literature. The system conserves more bone than traditional hip replacement, does not compromise future surgical options, including primary hip replacement, and offers patients a better range of natural motion and reduced dislocation risk, according to a company press release.

In September 2005, the FDA’s Orthopedic and Rehabilitation Devices advisory committee voted 4-to-2 to recommend approval of the BHR system. Some panel members voiced general satisfaction with the device’s efficacy and safety. However, others expressed concern over the size and scope of the patient cohort used in an uncontrolled study. They also expressed concern over safety data and the learning curve required for proper use. The panel conditioned its recommendation upon Smith & Nephew conducting a 10-year clinical and radiographic follow-up study based on “sound statistical principles.”

The current FDA approval letter follows the advisory committee’s recommendation and requires Smith & Nephew to carry out such postapproval studies.

Derek McMinn, FRCS, and Ronan Treacy, FRCS, of Birmingham, England, developed the BHR system, which Midland Medical Technologies first introduced in the United Kingdom in 1997. It has since been implanted in over 60,000 patients in 26 countries. Smith & Nephew plans to begin training 50 surgeons as part of the first phase of the U.S. introduction. Training will be provided in the United States and Europe, with the first U.S. surgeries expected to be completed this summer.