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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.


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TVAM Procedure

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.

TVAM Complications

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.

FDA Safety Concerns Over TVAM

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.

There is no clear scientific evidence to support that the treatment of internal jugular venous stenosis is safe in any patients.

Transvascular Autonomic Modulation (TVAM) Legal Help

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Angioplasty TVAM, Doctors and the FDA
Angioplasty TVAM, Doctors and the FDA
May 19, 2017
Washington, DC: Angioplasty was designed as a safe alternative to open heart surgery, but a procedure using balloon angioplasty devices called transvascular autonomic modulation (TVAM) is not safe, which the FDA has warned of repeatedly. Some doctors, however, believe its benefits outweigh the risks involved.

FDA Warns Against Off Label Angioplasty Treatment Known as TVAM
FDA Warns Against Off Label Angioplasty Treatment Known as TVAM
April 17, 2017
Dallas, TX The FDA is taking the unusual step of calling out a specific doctor and warning people to steer clear of the use of TVAM angioplasty as a treatment for serious illnesses such as Parkinson’s disease, Multiple Sclerosis and other autonomic disorders.


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