FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients
MedSun: Newsletter #73, June 2012

FDA MedWatch Safety Alert

At this time, the FDA believes there is no reliable evidence from controlled clinical trials that this procedure is effective in treating Multiple Sclerosis (MS). In addition, the criteria used to diagnose Chronic Cerebrospinal Venous Insufficiency (CCSVI) have not been adequately established. Therefore, data to support CCSVI as a clinical entity on its own or its relationship with MS are inconclusive and at times, contradictory.

Additional Information:

FDA MedWatch Safety Alert. FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients. May 10, 2012.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm303318.htm


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