For subscribers only. Entire article posted.
Johnson & Johnson received Food and Drug Administration approval for the first spinal-disc implant to replace deteriorated natural shock absorbers between the bones of the lower back. Degenerated discs are a leading cause of back pain and disability. By replacing damaged discs with a durable implant, spine surgeons hope to duplicate the success that other doctors have had substituting implants for damaged knees and hips.
Surgeons commonly treat chronic back pain by fusing the bones around the degenerated disc. The surgery, performed more than 200,000 times a year, limits spinal flexibility and doesn't always relieve pain. "The majority of these patients would be suited for disc replacement," said Scott Blumenthal, lead investigator of a large clinical trial of the disc, and an orthopedic spine surgeon from the Texas Back Institute in Plano. "I feel comfortable that these patients will be better served with the artificial disc."
The disc from Johnson & Johnson, New Brunswick, N.J., consists of a plastic core that slides between two metal end plates. The product, called the Charité artificial disc, is expected to cost $11,500, not including the surgery. Other companies, including Medtronic Inc., are working on rival implants. The artificial disc was studied in 205 patients, comparing them with 99 patients who had spinal fusions. Additional safety data were collected in 71 patients who received implants when doctors were trained in the procedure. |