Disk approved for spinal relief
The Food and Drug Administration has granted approval for the first artificial spinal disk for use in patients suffering from persistent lower back pain.
The Charite artificial disk is made by DePuy Spine Inc., of Raynham, Mass. Artificial disks have long been used in Europe. The approval was granted Tuesday.
The disk, a plastic core sandwiched by two metal plates, is intended as an alternative to spinal fusion surgery. The operation can sometimes alleviate pain, but it can also put more pressure on other disks.
More than 200,000 Americans undergo spinal fusion surgery each year. During surgery, the damaged disk is removed and bones on either side are grafted together.
Government approval followed a study by DePuy Spine that found that two years after surgery, patients with the artificial disk did no worse than those who had spinal fusion surgery, the FDA said.
The company was more glowing in its own assessment of the product, issuing a statement saying that patients who received the artificial disk left the hospital sooner and were more satisfied than those who had fusion surgery.
The FDA said the disk could be implanted only in patients who have degenerative disk disease and who have had no relief from back pain after at least six months of nonsurgical treatment.
Surgeons place the artificial disk in the spine through a small incision just below the bellybutton. Patients are given general anesthesia.
The bones of the spine have spongy disks between them, tough collagen rings surrounding a fluid-filled cushion, which act as shock absorbers. They keep vertebrae properly separated, cushioned and flexible.
A disk damaged by injury or aging can cause intense pain, especially if nerves are crunched or the disk degenerates enough that bone grinds on bone.
Millions of Americans suffer back pain, often caused by a degenerating disk. Time, painkillers and special exercises help most recover.
The FDA directed DePuy Spine to conduct another study to measure the product’s long-term safety and effectiveness, including its effect on other disks.
