In a meeting held late last month, FDA's panel on orthopedic and rehabilitation devices recommended approval of the Cormet 2000 hip resurfacing system, manufactured by Corin Group plc (Gloucestershire, UK). If approved as recommended, the Cormet implant would be the second such device to gain access to the U.S. market. The Birmingham hip replacement system, manufactured by Smith & Nephew plc (London), received FDA approval last May.
Corin, which claims to be one of the originators of hip resurfacing, says that its device, which is currently available in 50 countries, combines the principles of conservative arthroplasty with metal-on-metal bearing technology. The procedure is intended for the treatment of younger, more-active patients with osteoarthritis or rheumatoid arthritis of the hip. In contrast to the more-traditional total hip replacement surgery, resurfacing is less invasive and preserves much of the femur. Resurfacing reshapes the bone before it is capped with a metal prosthesis. As in total hip replacement, the socket is also fitted with a metal prosthesis.
Proponents claim that resurfacing, with its with metal-on-metal bearing technology, results in a stable joint that is thought to be more durable, while reducing the risk of postoperative dislocation. Yet it is generally acknowledged that many candidates for hip resurfacing may eventually require a total joint replacement. If such is the case, the procedure conserves enough of the femoral head to perform total hip arthroplasty.
In approving the Cormet 2000 in a 4-1 vote, the FDA panel recommended that final marketing clearance require postmarket studies, detailed labeling for the implant and its indications for use, and a program of surgeon education and training.
The training requirement is thought to be a key component if hip resurfacing is to live up to the expectations of its current potential. The operation is typically seen as a more difficult procedure than total joint replacement, and only a small percentage of orthopedic surgeons are currently qualified to perform it.
Orthopedic surgeons continue to report a growing demand for osteoarthritis relief from younger patients, many of whom continue to engage in vigorous physical activities and competitive athletics well into their adult lives. While hip resurfacing is generally recognized as unsuitable for most patients, the procedure is expected to emerge as a viable option for this group.
Commenting on the panel's favorable decision, Ian Paling, Corin's chief executive officer, said, "We are now poised, subject to final FDA approval, to be able to supply the world's largest orthopedic market with our leading hip resurfacing product. We are very confident that the opportunities for Cormet in the United States are substantial, as all our market research points to significant demand for this hip resurfacing technology, which is especially attractive to the younger, active baby-boomer generation."
Stryker Corp. (Kalamazoo, MI) has the exclusive rights to market the Corin Cormet 2000 in the United States. With its large sales force, the company is expected to be a formidable competitor to Smith & Nephew.
PJC's Denhoy: Stalled progress at Wright.
Wright Medical Technology Inc. (Arlington, TN) was the first medtech firm to seek FDA approval of a hip resurfacing system. However, according to Raj Denhoy, senior research analyst with Piper Jaffray & Co. (Minneapolis), Wright's application for the Conserve Plus implant is "stalled . . . and the company has not provided any explanation."
Other hip replacement systems either in development or available outside the United States include the ReCap from Biomet Inc. (Warsaw, IN); the ASR from DePuy Orthopedics Inc. (Warsaw, IN), a Johnson & Johnson company; the Bionik from ESKA Implants GmbH (Lübeck, Germany); the ADEPT from Finsbury Orthopedics Ltd. (Surrey, UK); the Icon from International Orthopedics GmbH (Geisingen, Germany); and the Durom from Zimmer Holdings Inc. (Warsaw, IN).
Hip resurfacing received a great deal of attention at last month's meeting of the American Academy of Orthopedic Surgeons (Rosemont, IL). Most of the sessions on the procedure generally reported positive findings. However, the procedure remains a controversial subject within the orthopedic surgeon community, as concerns have been raised by reports of higher than expected early failure rates, larger incisions, and greater blood loss during surgery than initially expected. Since the procedure is relatively new, there are increasing calls for more long-term studies on the performance of implants used in hip resurfacing.
Currently commanding a 20% premium over traditional total joint replacement, hip resurfacing is often not covered by health insurance. Increasing competition is expected to put downward pressure on prices.Analyst Denhoy expects Corin's implant to gain full FDA approval before the end of the year. He believes resurfacing has a valuation potential of $200 million to $400 million and is likely to capture 10-15% of the U.S. hip replacement market.
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