Johnson & Johnson
said Tuesday that the Food and Drug Administration had approved its Charite artificial disc, the first such device for treating lower back pain. Charite replaces damaged or worn-out spinal discs.
The FDA approval wasn't a surprise. An FDA advisory committee in early June unanimously recommended the device developed by J&J's DePuy Spine unit.
J&J said the product could provide an alternative to spinal fusion for some of the 200,000 Americans who undergo the operation each year. Spinal fusion helps reduce back pain but it also reduces one's range of motion.
The artificial disc is made of two metal endplates and a polyethylene core that DePuy says functions similarly to a normal disc. The company said the artificial disc has been implanted in 7,000 patients worldwide. The disc was first marketed overseas in 1987 and is now available in more than 30 countries.
One clinical investigator, Dr. John Regan, a spine surgeon at Cedars Sinai in Los Angeles, said the J&J device enabled patients to return to work and to normal activity sooner than his spinal fusion patients. "At our center, Charite Artificial Disc patients returned to work in 12 weeks or less, which was far better than the spinal fusion patients who were not able to go back to work for about six months," he said.
J&J noted that artificial disc replacement "is not for everyone." As with any major surgery, there are possible complications that can occur, including "unresolved pain, allergic reactions, bladder problems and/or infection," the company said. "Patients should ask their doctors to see if artificial disc replacement is appropriate for them."
J&J's stock lost 4 cents to $57.04.