The Food and Drug Administration yesterday permitted a unit of Johnson & Johnson to market an artificial spinal disk in the United States as a new form of treatment for people with severe lower back pain.
The disc, called the Charité (pronounced shar-ee-TAY), represents the first of a wave of such devices that are expected to become available over the next decade as an alternative to spinal fusion surgery.
Spinal disk implants are projected to become a billion-dollar market for medical device companies in the next decade, although many orthopedics researchers think that artificial disks will eventually be overtaken by less invasive treatments.
Johnson & Johnson will market the device for use only in the portions of the lower spine for which it has F.D.A.-approved clinical data. Surgeons say the device, which consists of a high-density plastic sandwiched between two metal plates, can be used only on patients with relatively strong bones.
Disks are gel-like cushions that separate the bones of the spine. In spinal fusion, surgeons insert metal plates or rods into the bones of the spine above and below a failing disk to hold them in place.
Then bone material is inserted so that the spinal bones become fused. More than 200,000 Americans undergo spinal fusion annually for pain relief from disk degeneration in the lower spine.
Orthopedic surgeons and medical device companies are excited about the potential of artificial disks because patients recover more quickly and have more freedom of movement than after spinal fusion. In addition, spinal fusion typically puts additional pressure on the disks above and below the fused segment of the spine, which often leads to the need for more back surgery.
“The idea of the disk is very appealing,” said Dr. John A. Boockvar, assistant professor of neurological surgery at New York Presbyterian Hospital/Weill Medical College of Cornell. Dr. Boockvar said that cervical disks, which could be inserted in the neck portion of the spine and are under development at several companies, would be an even more welcome development because freedom of movement was more crucial for the neck.
DePuy Spine, the Johnson & Johnson unit that will market the Charité, is based in Raynham, Mass. DePuy acquired the rights to the Charité when it paid $325 million last year for Link Spine Group. The Charité has been implanted in thousands of European patients since the mid-1980’s, after it was developed at the Charité Clinic in Berlin.
Analysts said that DePuy would have the domestic market to itself for as long as two years but that it would face strong competition in the long run from Medtronic, Synthes-Stratec and other device makers.
Lawrence Keusch, who follows device companies for Goldman Sachs, estimated that disks for the lower spine would take no more than 20 percent of the lumbar spinal fusion market, generating $340 million in revenue, and that sales would initially be slow because so few surgeons have been trained to do the implants.
