First Artificial Spinal Disc Cleared for U.S. Market

The first artificial disc for the spine, a metal-and-plastic implant made by Johnson & Johnson, won U.S. approval on Tuesday for treating severe lower back pain.

The first artificial disc for the spine, a metal-and-plastic implant made by Johnson & Johnson, won U.S. approval on Tuesday for treating severe lower back pain.The disc called Charite is designed to replace a natural disc — one of the shock-absorbing pads between vertebrae — after it becomes damaged.The new disc, made of two metal endplates and a plastic core, offers an alternative to surgery that fuses two bones in the lower spine. The fusion surgery often relieves pain but restricts a patient’s range of motion and can strain nearby discs, requiring further surgery.Johnson & Johnson said the Charite disc alleviates pain while helping to maintain mobility in the lower back.The Food and Drug Administration, however, said the disc does not always allow movement at the implant area, and sometimes allows too much movement, which can place excess stress on the device. The agency is requiring Johnson & Johnson to further study the product’s long-term safety and effectiveness.The FDA cleared the disc for patients with degenerative disc disease in the lower spine who have had no pain relief despite at least six months of non-surgical treatment.The disc is an appealing option because fusion surgery is not always successful, said Robert Haralson, executive director of medical affairs for the American Academy of Orthopaedic Surgeons. But he said he would like to know how the device performs after four or five years.”We just need more long-term data before everybody in the world ought to start doing this,” Haralson said.Johnson & Johnson studied the disc in 205 patients, comparing them to 99 others who had spinal fusion aided by a cage-like device that helps hold bones together. Safety information also was collected from 71 other disc recipients.Two years after the surgery, artificial disc patients fared no worse than patients who had fusion surgery, the FDA said. Complication rates were similar with both treatments.Johnson & Johnson said disc patients left the hospital sooner and were more satisfied with the procedure, which involves a small incision below the belly button through which surgeons remove the damaged disc and place the artificial one. Patients must have general anesthesia.More than 200,000 U.S. patients undergo spinal fusion surgery each year.Industry analysts predict only a minority of fusion candidates will opt for an artificial disc in the next couple years. Annual sales for artificial discs may hit $100 million in 2006, and eventually top $1 billion, Merrill Lynch analyst Daniel Lemaitre has predicted.Charite has been sold in Europe for more than a decade.Medtronic Inc., Synthes Inc. and privately held Spinecore also are developing artificial discs for the lower back as well as the neck.Johnson & Johnson shares gained 15 cents on Tuesday to close at $57.23, while Medtronic shares rose $1.10, or 2.2 percent, to close at $50.67, both on the New York Stock Exchange.Before the announcement, Synthes shares closed down 1.30 Swiss francs, or 1 percent, to close at 128 Swiss francs in Swiss trading. (Additional reporting by Susan Heavey in Washington and Julie Steenhuysen in Chicago)(Source: Reuters, Oct 2004)