FDA News

Stryker to Market FDA Approved Hip Resurfacing System In Third Quarter of 2007

(July 29, 2007)-- Stryker Corporation announced that it will begin marketing Corin Group PLC's Cormet Hip Resurfacing System as early as the third quarter of this year. This follows today's FDA approval of Cormet and is predicated on a comprehensive surgeon education protocol developed by Stryker and Corin, in cooperation with the FDA, emphasizing patient selection criteria to promote successful outcomes. Stryker's Orthopaedics division previously secured an exclusive 10-year agreement to market and distribute the Cormet Hip Resurfacing System in the United States.

Interest in hip resurfacing procedures is on the rise globally due to the bone conserving nature of the procedure and anticipated potential benefits related to post-operative activities and range of motion. In these procedures, surgeons replace the acetabulum in much the same way as a conventional total hip but the femoral head is resurfaced rather than removed. Hip resurfacing is viewed by many surgeons as an alternative to traditional hip replacements to help patients indicated for the technology return to their active lifestyles.

Corin is the first manufacturer to receive FDA approval based on a U.S. prospective, multi-center, clinical study that highlights the importance of appropriate patient selection and surgeon education for this emerging technology segment. The results support the need for surgeons to focus on several key anatomic and physiologic factors when determining if resurfacing is the right option for a patient.

"Hip resurfacing offers the right patient a more conservative, bone preserving procedure than traditional hip replacement. The anatomic nature of these devices enables certain younger, more active patients to get back to the activities that are important to them," said, Bernard Stulberg, M.D., Director, Cleveland Center for Joint Reconstruction. He added, "the dialogue between surgeon and patient will be more critical than ever in determining which anatomic option is right for the patient."

Stryker is committed to providing surgeons with the appropriate patient selection information, tools and training to drive positive patient outcomes. As such, a comprehensive surgeon education protocol has been developed in cooperation with Corin and the FDA to enable U.S. surgeons to perform the technique properly and with confidence.

"Resurfacing is an important extension of our hip portfolio which focuses on providing personalized solutions based on the unique needs of a diverse patient population. Stryker remains dedicated to introducing technological advancements that help improve patient outcomes," said Mike Mogul, President, Stryker Orthopaedics.

Stryker plans to initiate surgeon training programs in the third quarter of 2007. Corin will begin supplying product in conjunction with the schedule for these programs.

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