In June, 2004, the FDA Advisory Panel unanimously recommended the approval of the first Artificial Disc for degenerative disc disease. The FDA is expected to approve the Charite™ Artificial Disc available through DePuy, Inc., a Johnson & Johnson company, sometime in September, 2004.
DePuy Spine, Inc. presented results from a two-year, 15 center randomized U.S. clinical study to the advisory panel. The study states that “patients reported that they maintained or improved their range of motion, experienced pain relief sooner, and had a higher degree of satisfaction with the procedure than patients who received lumbar spinal fusion surgery. Their level of pain and functional test scores were statistically superior at many points through 12 and at 24 months of follow-up care”.
Previously, a degenerative or herniated disc had to be removed, and the vertebrae had to be fused together with bone or with surgical hardware. Now, surgeons will remove the disc and replace it with the new Charite™ Artificial Disc. This disc is intended to provide an alternative to lumbar spinal fusion surgery that is performed on more than 200,000 people each year in the U.S. Locally, the surgeons at Southern NY Neurosurgical Group, P.C. have been chosen as one of only seven training teams in the entire eastern region of the U.S., including, Maine, Washington, D.C. and Ohio to teach other neurological and orthopedic surgeons how to perform the artificial disc surgery.
“This is the biggest step forward in spine surgery in decades, exclaimed Dr. Saeed A. Bajwa, neurosurgeon at Southern NY Neurosurgical Group, P.C. “It will change the way people with disc problems live. With this replacement disc, we can rebuild the spine to function normally.”
The surgical training will take place at Wilson Regional Medical Center in Johnson City, N.Y., a hospital in the United Health Services system. (“Quote from UHS” here). Hundreds of surgeons from around the country will be trained on how to perform artificial disc surgery, a critical advancement in lumbar spine surgery.
Earl Fender, Worldwide President, DePuy Spine said, “We are pleased with the recommendation for approval and we will work closely with the FDA to bring this important new option to those patients who can benefit from artificial disc technology as soon as possible. DePuy Spine is prepared to make a major commitment to world class training and education on artificial disc technology and techniques to foster its optimal and appropriate use.”Leave a reply
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