The Food and Drug Administration (FDA) is cautioning the public about transvascular autonomic modulation (TVAM), an experimental procedure being promoted as a treatment for a variety of conditions though it has not been formally studied in trials.
TVAM uses balloon angioplasty devices that are not within the scope of the FDA-approved indications. The procedure consists of threading a catheter into a patient’s venous system where a balloon attached to the catheter inflates to widen the vein walls. It has been claimed that the procedure treats the signs and symptoms of autonomic dysfunction in various neurological disorders (eg, Parkinson’s disease, multiple sclerosis, fibromyalgia, multiple system atrophy, postural orthostatic tachycardia syndrome, peripheral neuropathies, primary dysautonomia, familial dysautonomia).However, the FDA has not evaluated any data that supports the safety and efficacy of balloon angioplasty devices for this use.
The FDA is alerting physicians and potential clinical investigators that the FDA has not cleared or approved any balloon angioplasty devices for the treatment of autonomic dysfunction. The Agency has also not been presented with data to support the use of these devices in treating autonomic dysfunction. There is no clear scientific evidence to support that the treatment of internal jugular venous stenosis is safe in any patients, impacts the symptoms of autonomic dysfunction, changes the overall course of health conditions derived from autonomic dysfunction, or improves the quality of life for patients with autonomic dysfunction.
Physicians and patients should discuss the benefits and risks of the available treatments for autonomic dysfunction, including adverse events related to catheter-guided endovascular intervention and balloon angioplasty devices for TVAM. Physicians should inform patients that TVAM is experimental and that the FDA has not been presented with any data in order to assure the safety and efficacy of the devices used in this procedure.
After the FDA’s safety communication in May 2012, there has been at least one medical device report of a balloon rupturing during placement in a patient’s jugular vein. Other serious events reported include at least one death, blood clots in a vein in the brain, cranial nerve damage, and abdominal bleeding.
Patients who have had the procedure done should be monitored for potential complications (eg, excessive pain, discomfort, bruising, excessive bleeding from puncture site, stroke, stroke-like complications).
The FDA will continue to investigate this situation and inform the public as new information becomes available.
For more information call (888) 463-6332 or visit FDA.gov.