People who suffer from a spinal problem that can cause back and leg pain have an alternative to difficult surgery with a newly approved device that requires a much less invasive procedure to implant.
However, FDA documents released last year before a public hearing on the product raise concerns that the X-stop’s effectiveness decreases over time, saying studies found that about 15 percent of patients who had the implant reported symptoms returning.
“It appears that the X-stop is effective to about a year and then begins to decline,” the FDA said.
Dr. Zucherman disputed those figures, saying the percentage of implant patients Active Release Technique Traverse City reporting a dropoff was about half that and that people who received only therapy and drug treatments reported a much greater rate of symptoms returning.
The documents also say roughly 50 percent of people who received the implant said they had a significant relief of all symptoms related to stenosis, as opposed to 5 percent who reported relief from nonsurgical treatment.
Zucherman pointed to another figure provided to the FDA that 73 percent of patients who received the implant reported being satisfied with it after two years. People who underwent laminectomies report similar success rates, he said.
The treatment is also less expensive than the more invasive alternative. Implanting a single X-stop costs about $17,000; implanting two costs $24,000, he said. A laminectomy is about $50,000.
About 4,000 X-stop devices have been implanted around the world, he said.
https://secure.assets.tumblr.com/post.jsVersions of the device are already available in Europe and Japan. About 400,000 Americans are affected annually by lumbar spinal stenosis.
Zucherman said he invented the device in 1997 after watching a patient who received a successful laminectomy become mentally disabled he couldn’t remember where he was moment to moment because of the full anesthesia used.