Safety Communications > Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients: FDA Safety Communication

Safety Communications > Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients: FDA Safety Communication

FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction 

Today, FDA posted a safety communication that warns patients and health care providers about an experimental procedure called Transvascular Autonomic Modulation (TVAM). This procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials. The procedure uses balloon angioplasty devices outside the scope of the FDA-approved indications for use to widen a patient’s veins. 

This safety communication supplements a 2012 FDA safety communication and an FDA warning letteraddressing the risk of serious injuries and death associated with a  similar experimental procedure, using the same medical devices, to treat Chronic Cerebrospinal Venous Insufficiency (CCSVI).

For additional information, go to TVAM.

Helene D. Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration