Balloon Angioplasty Procedures For Autonomic Dysfunctions Unproven, FDA Warns

Federal regulators are warning consumers and the medical community about the risks associated with use of an unapproved and experimental balloon angioplasty procedure designed to treat autonomic dysfunctions, such as Parkinson’s disease, multiple sclerosis, fibromyalgia and others. 

In a safety communication issued on March 8, the FDA indicates that some doctors are using a procedure approved for angioplasty “off-label”, which is not approved by the agency and may pose serious risks for patients.

In these experimental procedures, doctors use balloon angioplasty devices outside of the FDA-approved scope of indications. Known as Transvascular Autonomic Modulation (TVAM), the procedure threads a catheter into the patient’s vein, such as the jugular vein. The balloon attached to the catheter inflates to widen the vein walls.

One doctor in particular, Dr. Michael Arata, claims this experimental procedure treats the signs and symptoms of many neurological disorders, including Parkinson’s disease, multiple sclerosis, fibromyalgia, multiple system atrophy, postural tachycardia syndrome (POTS), peripheral neuropathies, primary dysautonmia, and familial dysautonomia.

The FDA is warning patients who are seeking treatment for these conditions not to use this type of procedure. The agency is also warning doctors who treat these conditions, such as neurologists, and other healthcare providers, like vascular surgeons and neurosurgeons, not to use TVAM to treat those neurological conditions.

Using the experimental treatment in this way is not approved by the FDA, for these conditions and it may put patients at risk. It has not been formally studied in clinical trials and its “safety and effectiveness” is not established for unapproved conditions.

The FDA also indicates that there is no clear scientific evidence to support treatment of jugular venous stenosis in any patient with autonomic dysfunction.

To date, the FDA received one report of a balloon rupturing during the placement in the jugular vein. The balloon migrated to the patient’s lung and the patient required surgery to remove the ruptured balloon.

Other serious side effects may arise from this procedure, including death, blood clots in the veins in the brain, stroke, cranial nerve damage, abdominal bleeding, pain, and excessive bleeding at the balloon thread site.

The FDA issued a warning letter to Dr. Arata, calling on him to stop the experimental procedures. The FDA indicates that he has continued to conduct what it considers unauthorized clinical research.