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www.fdanews.com/articles/91059-advisory-panel-gives-hip-resurfacing-device-thumbs-up-with-conditions

ADVISORY PANEL GIVES HIP RESURFACING DEVICE THUMBS UP, WITH CONDITIONS

February 23, 2007

Corin has overcome several obstacles -- including patients refusing to participate in the control arm of its clinical study -- to gain a favorable FDA advisory committee panel vote of 4-1 recommending that the agency allow the firm to market its joint device. The panel's recommendation is based on the firm taking certain postapproval actions.

The FDA's Orthopaedic and Rehabilitation Panel met Feb. 22 to consider UK-based Corin's premarket approval application for its Cormet 2000 hip resurfacing system as a "noninferior" option to total hip replacement (THR).

Hip resurfacing, also called hip surface replacement, involves the reshaping of the femoral head -- the head section of the femur -- to accept a metal cap with a small guide stem, which fits into a metal cup set into the pelvis. In standard THR, the femoral head and neck are removed, the femoral canal is reamed out and a metal stem is secured in the canal.

MarketWatch reported that Corin shares jumped more than 30 percent following news of the panel's approval recommendation.