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FDA approves new hip resurfacing system, but with conditions
The agency predicated the approval on a comprehensive surgeon education protocol emphasizing patient selection criteria.
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KALAMAZOO, Mich. — Stryker will begin marketing Corin Group PLC's Cormet Hip Resurfacing System as early as the third quarter of this year, the company announced in a press release.
The announcement follows the FDA's approval of the Cormet resurfacing system earlier this week, which the agency predicated on a comprehensive surgeon education protocol developed by Stryker and Corin in cooperation with the FDA. This education protocol emphasizes patient selection criteria to promote successful outcomes, according to the release.
Stryker plans to initiate the surgeon training programs in the third quarter of 2007. The company's orthopedics division had earlier secured an exclusive 10-year agreement to market and distribute the Cormet hip resurfacing system in the United States. Corin will begin supplying the product in conjunction with the schedule for the surgeons training programs, the release said.
Corin is the first manufacturer to receive FDA approval for a hip resurfacing system based on a U.S. prospective, multi-center clinical study, which highlighted the importance of appropriate patient selection and surgeon education. The study results also support the need for surgeons to focus on several key anatomic and physiologic factors when determining whether hip resurfacing is the right surgical option for a patient, the release said.
In February, the FDA Orthopaedic and Rehabilitation Devices Panel voted to recommend the device for approval with conditions, including that Corin conduct a 10-year post-marketing approval study.