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FDA Warning for Transvascular Autonomic Modulation (TVAM)
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The Food and Drug Administration (FDA) has issued a safety alert regarding an experimental procedure called Transvascular Autonomic Modulation (TVAM). This procedure may put patients at risk because it is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials. Reported risks include TVAM balloon rupture and TVAM balloon migration, potentially leading to blood clots, nerve damage and even death. The TVAM procedure uses balloon angioplasty devices outside the scope of the FDA-approved indications for use.
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 has not reviewed any data that supports the safety and effectiveness of balloon angioplasty devices for this intended use.
For people with autonomic dysfunction, which includes but is not limited to Parkinson’s disease, MS, fibromyalgia, multiple system atrophy, POTS, peripheral neuropathies, primary dysautonomia, and familial dysautonomia, TVAM and other similar experimental procedures have been associated with serious complications. After an FDA safety communication issued in May 2012 , the agency 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 discussed 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.
The FDA believes that performing a TVAM procedure using these medical devices poses a risk to patients because the safety and effectiveness of using balloon angioplasty devices in a patient’s venous system has not been established for any clinical condition. The FDA has approved these devices for use only in arteries.
FDA Safety Concerns Over TVAM
There is no clear scientific evidence to support that the treatment of internal jugular venous stenosis is safe in any patients.
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