FDA OKs Hip Resurfacing for Stryker
KALAMAZOO — Stryker Corp. will begin marketing Corin Group PLC's Cormet Hip Resurfacing System as early as the third quarter of this year, following the Federal Drug Administration’s July 3 approval of the system.
Marketing 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.
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 some patients return to active lifestyles.
FDA approval of Cormet is based on a
"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 Dr. Bernard Stulberg, director of the
Stryker plans to initiate surgeon training programs in the third quarter of 2007. Corin will begin supplying products in conjunction with the training.
Stryker's orthopaedics division previously secured an exclusive 10-year agreement to market and distribute the Cormet Hip Resurfacing System in the United States.