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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.

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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.

The agency in March 2017 issued a warning to patients with autonomic dysfunction (nervous system disorders), including Parkinson’s disease, multiple sclerosis (MS), fibromyalgia, multiple system atrophy and more, and doctors who use balloon angioplasty devices to treat them. TVAM has not been approved or formally studied and it could put patients at risk of serious complications. But one doctor continues to use the device “off-label”, saying the benefits of this procedure are “usually seen immediately.” He also treats Lyme disease with TVAM rather than antibiotics and explains it in a video.

In September 2016 the FDA put Dr. Arata of Newport Beach, California on notice by way of “Initiation of Disqualification Proceedings and Opportunity to Explain”

(NIDPOE), to determine whether he should be disqualified from receiving investigational products under FDA’s regulations. Arata claims the angioplasty TVAM procedure treats the signs and symptoms of autonomic dysfunction in some neurological disorders, but the FDA says it has no data to indicate such claims. Rather, the agency says that TVAM is an experimental treatment that has been associated with at least one death.

Back in May 2012, the FDA warned of the risks involved with a similar procedure. The same balloon angioplasty devices were used to treat chronic cerebrospinal venous insufficiency (CCSVI). Reports of serious complications included one patient who died from bleeding in the brain and another patient suffered permanent paralysis from a stroke after CCSVI treatment. Are doctors aware of the FDA reports regarding balloon angioplasty and choose to use the device off-label, potentially putting their patients at risk? The agency received a report after this 2012 warning that a balloon ruptured while being placed in a patient’s jugular vein. The device moved to the patient's lung, where it was surgically removed.

A warning letter (February 2012) was sent to Dr. Manish Mehta, whose practice in Albany, New York was investigated by the FDA. “The inspection was conducted under a program designed to ensure that data and information contained in requests for Investigational Device Exemptions (IDE), Premarket Approval applications, and Premarket Notification (510(k)) submissions are scientifically valid and accurate. Another objective of the program is to ensure that human subjects are protected from undue hazard or risk during the course of scientific investigations.” The agency found that Mehta had violated a clinical study by failing to submit correct documentation before patients were treated with the balloon angioplasty device.

Back to March 2017: Canadian researchers at the University of British Columbia and Vancouver Coastal Health reported results from a study that involved 104 patients with MS treated with angioplasty TVAM, according to the Associated Press. The patients did no better with TVAM than those without the procedure. And the FDA’s case against Arata is on hold: to be continued

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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