The Food and Drug Administration (FDA) is cautioning people with disorders of autonomic nervous system function, such as Parkinson’s disease and multiple sclerosis, who are considering an experimental treatment called Transvascular Autonomic Modulation (TVAM), that the procedure has not been formally studied in clinical trials and may put patients at risk for complications.
TVAM is being promoted to treat a variety of autonomic dysfunctions, including Parkinson’s disease, multiple sclerosis, fibromyalgia, multiple system atrophy, postural tachycardia syndrome (POTS), peripheral neuropathies, primary dysautonomia, and familial dysautonomia. The procedure uses balloon angioplasty devices outside the scope of the FDA-approved indications for use.
In 2012, the FDA issued a Safety Communication and Warning Letter addressing serious injuries and death associated with a similar experimental procedure using the same medical devices to treat Chronic Cerebrospinal Venous Insufficiency (CCSVI).
TVAM consists of threading a catheter into a patient’s venous system, such as the jugular vein, where a balloon attached to the catheter inflates to widen the vein walls. “At least one physician, Dr. Michael Arata, claims the procedure treats the signs and symptoms of autonomic dysfunction in a number of neurological disorders,” the FDA stated in a recent Safety Communication. The agency says it has not reviewed any data that supports the safety and effectiveness of balloon angioplasty devices for this use.
“TVAM and other similar experimental procedures have been associated with serious complications,” the FDA warned. Following a May 2012 safety review, the FDA said it received at least one medical device report of a balloon rupturing during placement in a patient’s jugular vein.
“Physicians ultimately determined the balloon had migrated to the patient’s lung, requiring surgery to remove the ruptured balloon. Other serious complications reported to the FDA or published in medical journals include at least one death, blood clots in a vein in the brain (which may lead to a stroke), cranial nerve damage, and abdominal bleeding,” FDA reports.
“The FDA continues to monitor for adverse events related to medical devices used in experimental procedures for the treatment of symptoms associated with autonomic dysfunction, and will take action when appropriate,” the agency said.
Anyone who has undergone a TVAM procedure or is a caregiver of someone who has undergone TVAM who was experienced adverse events should file a report with the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.