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FDA: Experimental treatment for CCSVI poses risks

Friday May 11, 2012
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The U.S. Food and Drug Administration has alerted healthcare professionals and patients about injuries and deaths associated with the use of an experimental procedure sometimes called "liberation therapy" or the "liberation procedure" to treat chronic cerebrospinal venous insufficiency.

Some researchers believe that CCSVI, which is characterized by stenosis in the neck and chest, may cause multiple sclerosis or contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord. However, studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.

"Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS," William Maisel, MD, MPH, chief scientist and deputy director for science in the FDAs Center for Devices and Radiological Health, said in a news release. "Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes."

The experimental procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. However, the FDA has learned of death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the procedure. Balloon angioplasty devices and stents have not been approved by the FDA for use in treating CCSVI.

For physicians and clinical investigators planning or conducting clinical trials using medical devices to treat CCSVI, the FDA has passed along notification that such trials must comply with FDA regulations for investigational devices. Any procedures conducted are considered significant-risk clinical studies, and require FDA approval as an investigational device exemption.

The FDA will continue to monitor reports of adverse events associated with "liberation therapy" or the "liberation procedure" and keep the public informed as new safety information becomes available.


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