The procedure is called transvascular autonomic modulation and involves threading a catheter with a balloon attached to it into narrowed veins and inflating the balloon to improve blood flow.
The FDA first warned against the use of this procedure as a treatment for nervous system disorders in 2012. That year, the FDA sent a warning letter to a known proponent of the procedure, Michael Arata, MD, former president of Synergy Health Concepts.
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“At least one physician, Dr. Michael Arata, claims the procedure treats the signs and symptoms of autonomic dysfunction in a number of neurological disorders,” said the FDA in the Wednesday safety communication. “The FDA has not reviewed any data that supports the safety and effectiveness of balloon angioplasty devices for this intended use.”
On September 13, 2016, the FDA issued another letter to Dr. Arata inquiring about a TVAM research study conducted without the federal agency’s approval. The FDA has initiated administrative proceedings to determine whether Dr. Arata should be disqualified from receiving investigational products.
Documented complications associated with the procedure include a balloon rupturing in a patient’s jugular vein and migrating to the lung where it required surgical removal. Blood clots, cranial nerve damage and abdominal bleeding were also reported.
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