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FDA OK's Simple Device For Spinal Pain

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Unread 11.26.05, 03:50 AM
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FDA OK's Simple Device For Spinal Pain

People who suffer from lumbar spinal stenosis, a condition that can cause back and leg pain, now have an simple alternative to difficult surgery.

The Food and Drug Administration just an extremely simple device that can be implanted with minimally-invasive surgery. Called the "X-stop," it is a thumb of titanium on a mount that fits to a vertebra in the lower back.

Affecting nearly half a million Americans, lumbar spinal stenosis is the most common cause of back surgery in people over 50. It occurs when the tube for nerves in the spine becomes constricted as a person ages. Pain, numbness and weakness usually occur when the person stands up.

Previously, the condition could be treated with physical therapy, anti-inflammatory drugs and injections, or by a laminectomy, a difficult surgery that involves full anesthesia and the removal of parts of bone and tissue to open up the canal in the spine.

The X-stop achieves a similar effect by pressing against parts of either side of a vertebra and opening pushing open the tube without removing of it.

"By wedging those bones apart, the tube is indirectly opened up," said X-stop inventor Dr. James Zucherman, medical director of San Francisco's St. Mary's Spine Center.

"The bones don't collapse on the nerves like they did before. The patient doesn't have to bend over to protect the nerves."

Because it is implanted so close to the surface of the skin, the X-stop usually requires only local anesthesia to insert. People may have up to two of them implanted in the lower spine.

Zucherman, who has overseen the implantation of more than 100 of the devices during trials, said he will recommend it to most people with the condition who don't benefit from physical therapy and drug treatments. He will only recommend a laminectomy if the device doesn't help.

The treatment is less expensive than the more invasive alternative, which ususally requires general anesthesia. Implanting a single X-stop costs about $17,000; implanting two costs $24,000. A laminectomy is about $50,000.

About 4,000 X-stop devices have been implanted around the world, he said. Versions of the device are already available in Europe and Japan.

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