FDA Warns Against TVAM Using Balloon Angioplasty Devices

FDA issued a warning to patients and physicians against an experimental procedure called transvascular autonomic modulation (TVAM) using balloon angioplasty devices. The agency said TVAM puts patients at risk for several reasons.

FDA issued a warning to patients and physicians against an experimental procedure called transvascular autonomic modulation (TVAM) using balloon angioplasty devices

Patients and doctors considering an experimental procedure called transvascular autonomic modulation (TVAM) for the treatment of autonomic dysfunction such as Parkinson’s disease, MS, or fibromyalgia, among others, should really do their homework.

According to FDA, TVAM could put patients at risk because it has not been formally studied, and it has been associated with at least one death, plus other serious complications. The procedure uses balloon angioplasty devices outside the scope of FDA-approved indications for use.

The experimental procedure involves a catheter being 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. Balloon angioplasty devices are only approved for use in arteries though, not in the venous system.

In its safety communication to physicians and patients, the agency calls out one doctor in particular, Michael Arata, who claims the procedure treats the signs and symptoms of autonomic dysfunction in some neurological disorders. FDA said it has not seen any data that supports Arata’s claims.

This also is not the first time Arata has attracted FDA’s attention for conducting unauthorized research using balloon angioplasty devices off label.

The agency issued a similar warning in May 2012 that addressed the risk of serious injuries and death associated with a similar experimental procedure, using the same devices, to treat chronic cerebrospinal venous insufficiency (CCSVI). After the warning was issued, FDA said it received a report of a balloon rupturing during placement in a patient’s jugular vein. The ruptured balloon ended up migrating to the patient’s lung and had to be surgically removed, FDA said.

There have also been reports of at least one death, blood clots in a vein in the brain, cranial nerve damage, and abdominal bleeding from using balloon angioplasty devices in TVAM or similar experimental procedures, the agency said.

Because Arata continues to conduct unauthorized research using balloon angioplasty devices off label, FDA said, “the expanded list of neurological disorders he claims to treat warrant an update to the 2012 safety communication on the subject.”

In a video published on YouTube on Aug.13, 2015, Arata, of Synergy Health in Newport Beach, CA, describes both TVAM as a treatment for autonomic dysfunction, or dysautonomia. Arata said the goal of the procedure is to restore balance, which in turn helps the body’s organ systems function better, and relieves symptoms related to those dysfunctions.

“Symptoms related to energy level, thermal regulation, cognition, and function of organs that require cycles, such as gastrointestinal and urinary systems are all improved following this procedure,” Arata said.

These benefits are usually seen immediately, according to Arata, but may diminish within two months in about 20% of patients. But that means 80% of patients who Arata has performed the procedure on have maintained the benefits, he said. At the time of the video’s recording, he claimed that some of his patients had maintained the benefits of the TVAM procedure for three years.

In September 2016, FDA notified Arata that the agency was initiating an administrative proceeding to determine whether he should be disqualified from receiving investigational products under FDA’s regulations.

 

Source: Amanda Pedersen, Qmed