WHO PULLED WHAT STRINGS????
FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology
Smith & Nephew Orthopaedics (NYSE: SNN; LE:SN) announced today that the U.S. Food and Drug Administration‘s Orthopedic and Rehabilitation Devices Advisory Panel recommended conditional approval of the Company’s pre-market approval application (PMA) for its BIRMINGHAM HIP◊ Resurfacing (BHR◊) technology. The Company submitted a PMA for its BHR◊ technology on July 19, 2004.
The conditions recommended by the panel relate to the post marketing trial follow-ups.
Smith & Nephew’s BHR◊ technology has been used in over 33,000 patients since 1997, and this procedure has demonstrated significant positive clinical endpoints in the United Kingdom, Germany and Australia. The hip resurfacing procedure involves the replacement of the articular surfaces of the femur and acetabulum, leaving the femoral head substantially preserved. The device is intended to relieve hip pain and improve hip function in patients who have adequate bone stock and who wish to lead active lives.
“With our unique OXINIUM◊ technology, the recent introduction of our ceramic-on-ceramic hip and this further step towards approval in the US of our BHR◊ technology, we are confident that Smith & Nephew will possess the broadest and most comprehensive portfolio of orthopaedic bearing surfaces,” said David Illingworth.
Smith & Nephew acquired Midland Medical Technologies and its principal product, BIRMINGHAM HIP◊ Resurfacing in 2004.
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