.

IF pain nerves emanate from a spot in the center of a vertebra (?), a way to “kill” those nerves could relieve chronic back pain. A surgical procedure has recently been given FDA Clearance to do just that. It involves inserting a large needle under X-ray guidance, usually under anesthesia, into the center of a vertebra, then passing through a wire into that location to kill the nerve center.

Some report that the procedure is “FDA Approved”, a rigorous process of showing safety and effectiveness. Others claim “FDA Clearance”. Those are not the same thing. FDA Clearance is given after only getting agreement that a new device is “substantIally equivalent” to a previously approved device – effectiveness has not ben proven to the FDA and safety is assumed. Consequently Medicare and most insurance plans do not cover the operation if only FDA Cleared.

As far as I can tell, the only clinical study has been done by the manufacturer of the device. It claims reduction of back pain that lasts for several years, at least. It has some risk and doesn’t give complete relief. This is hopeful, but full FDA Approval and reimbursement for the procedure awaits confirming studies, I assume.

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