FDA Warns MS Patients Against Unproven Stent Procedure

The U.S. Food and Drug Administration warned doctors and patients against the use of an unproven procedure known as “liberation therapy” that some physicians have touted as a treatment for multiple sclerosis.

The procedure uses a balloon-tipped catheter or a metal device called a stent to prop open narrowed blood vessels in the neck and chest that some investigators claim may exacerbate or even cause multiple sclerosis, a degenerative disease of the brain and spinal cord. The therapy has been linked to strokes, migration of the metal stents, damaged veins, blood clots, abdominal bleeding and death, the FDA said in a statement.

The unapproved treatment is used for chronic cerebrospinal venous insufficiency, which some doctors say may worsen multiple sclerosis by hindering blood flow from the brain and spinal cord, the agency said. No studies have conclusively linked multiple sclerosis to the condition and there is no accepted method to diagnose it, the FDA said.

“There is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS,” said William Maisel, deputy director for science in the FDA’s Center for Devices and Radiological Health, who called for study of the link between multiple sclerosis and narrowed veins. “Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist” or another doctor familiar with the procedure, he said in a statement.

Multiple sclerosis, a chronic inflammatory disease, affects about 400,000 Americans, according to National Multiple Sclerosis Society. It stems from damage to the myelin sheath, fatty tissue that protects nerve fibers in the brain and spinal cord used to conduct electrical impulses that control movement.

The condition is currently treated with medications, including Biogen Idec Inc. (BIIB)’s Avonex and Tysabri and Teva Pharmaceutical Industries Ltd. (TEVA)’s Copaxone.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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