FDA Warns Transvascular Autonomic Modulation Unproven, Risky

Megan Brooks

Disclosures

March 10, 2017

Transvascular autonomic modulation (TVAM) is an experimental procedure that uses balloon angioplasty devices outside the scope of the US Food and Drug Administration (FDA)–approved indications for use and may put patients at risk, the FDA warns in a safety communication.

With TVAM, a catheter is threaded into a patient's venous system, such as the jugular vein, where a balloon attached to the catheter inflates to widen the vein walls.

"The FDA has not reviewed any data that supports the safety and effectiveness of balloon angioplasty devices for this intended use," the agency said on March 8.

Healthcare providers who manage the care of patients with autonomic dysfunction, including neurologists, interventionalists (radiologists, vascular surgeons, and neurosurgeons), and clinical researchers, should be aware of this, the FDA said.

The same goes for patients considering treatment options for autonomic dysfunction, including but not limited to Parkinson's disease, multiple sclerosis, fibromyalgia, multiple system atrophy, postural tachycardia syndrome, peripheral neuropathies, primary dysautonomia, familial dysautonomia.

"TVAM is being promoted as a treatment for a variety of conditions even though it has not been formally studied in clinical trials," the FDA said.

According to the FDA, at least one physician, Michael Arata, MD, claims TVAM treats the signs and symptoms of autonomic dysfunction in several neurologic disorders.

On September 13, 2016, the FDA issued a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letter to Dr Arata for conducting a TVAM research study without the review and approval of the FDA. This letter states that the FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving investigational products pursuant to FDA's regulations.

The FDA says there is "no clear scientific evidence" to show that treatment of internal jugular venous stenosis is safe in any patient, including those with autonomic dysfunction; affects 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.

The FDA has not cleared or approved any balloon angioplasty devices for the treatment of autonomic dysfunction and has not been presented with data to support the use of such devices in treating autonomic dysfunction, the agency said.

The FDA advises physicians to "discuss the benefits and risks of all available treatments for autonomic dysfunction with patients, including the adverse events generally associated with catheter-guided endovascular intervention and those related specifically to use of balloon angioplasty devices for TVAM."

Patients should be informed that TVAM is experimental, the FDA said.

Patients who have undergone TVAM should be monitored for potential complications, such as excessive pain, discomfort, bruising, excessive bleeding from the puncture site, and stroke or stroke-like complications, the FDA advises. Any adverse effects from a TVAM procedure should be reported to MedWatch, the FDA safety information and adverse event reporting program.

The TVAM safety communication supplements a 2012 FDA safety communication and an FDA warning letter addressing the risk for serious injuries and death associated with a similar experimental procedure, using the same medical devices, to treat chronic cerebrospinal venous insufficiency, as reported by Medscape Medical News.

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