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 DePuy AcroMed Receives FDA Premarket Approval For Lumbar I/F Cage® with VSP Spine System® CLEVELAND, OH (February 2, 1999) - DePuy AcroMed today announced that the FDA has approved the Premarket Approval Application for its Lumbar I/F Cage® with VSP Spine System®, an implant used to treat degenerative disc disease by facilitating interbody fusion of the lumbar spine. Bill Tidmore, President of DePuy AcroMed, said, "This is outstanding news for spine surgeons and their patients. With tens of thousands of successful procedures and more than eight years of clinical use outside the United States, the Lumbar I/F Cage is truly an innovation for the surgical spine community. The implant system embodies the company's philosophy of load sharing by providing anterior column support with secure posterior fixation." The Lumbar I/F Cage, developed in conjunction with Dr. John Brantigan, a world-renowned orthopaedic surgeon at the Huebner Medical Center in San Antonio, Texas, uses a unique carbon fiber reinforced polymer material and rectangular design with struts and ridges to help support all anticipated loads of the spine. The implant is hollow to accept packing of autologous cancellous bone graft, the best possible bone for healing, and radiolucent so that the bone healing can be assessed by normal radiographic methods. The carbon fiber reinforced polymer material is the first of its kind to be used in a device approved in the United States for an orthopaedic application. DePuy AcroMed is a division of DePuy, Inc., a Johnson & Johnson company, the world's oldest orthopaedic company and one of the leading designers, manufacturers, and distributors of orthopaedic devices and supplies. DePuy's products are used primarily by orthopaedic medical specialists and in the case of the Company's spinal implants, by orthopaedic, spinal and neurosurgeons, in both surgical and non-surgical therapies to treat patients with musculoskeletal conditions resulting from degenerative diseases, deformities, trauma and sports-related injuries. |
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