FDA Warns of Experimental Procedure for Autonomic Dysfunction
The FDA has issued a safety warning about an experimental balloon angioplasty procedure.
The US Food and Drug Administration (FDA) is warning physicians and patients alike to avoid an experimental procedure that is being touted as a treatment in autonomic dysfunction, including Parkinson disease, multiple sclerosis, multiple system atrophy, fibromyalgia, neuropathies, and more.
The procedure – transvascular autonomic modulation (TVAM) – involves performing a modified balloon angioplasty in a patient's venous system, typically through the jugular vein, in order to widen vein walls. The experimental treatment utilizes balloon angioplasty devices outside of their approved FDA indication, and there is no formal clinical trial data to support their use in the treatment of autonomic dysfunction.
This latest safety warning follows a similar communication issued by the FDA in 2012 regarding the use of this procedure to treat chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. Dubbed “liberation therapy,” the FDA warned at the time of serious risk of death or injury in patients considering the unproven treatment, and notified physicians and clinical investigators with plans to conduct trials of the medical procedure that they must comply with FDA regulations regarding investigational devices.
Despite previous warnings and no formal evidence that the procedure improves symptoms of or changes the disease course of conditions associated with autonomic dysfunction, it appears that at least 1 physician, who the FDA identified as Michael Arata, MD, continues to promote and conduct this procedure in patients with neurological disorders. As a result, the FDA issued a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain letter to Dr Arata in September 2016.
Serious adverse events associated with TVAM that have been documented include balloon rupture (requiring surgery to remove the device), cerebral venous thromboembolism, cranial nerve damage, abdominal bleeding, and death.
The FDA reminds physicians and potential clinical investigators that balloon angioplasty devices have not been approved for the treatment of autonomic dysfunction, nor is there evidence to support the use of angioplasty devices for this indication. Physicians should openly discuss available treatments for autonomic dysfunction with their patients, and point out the risks associated with endovascular interventions and TVAM, specifically. If physicians become aware of a patient who has undergone TVAM or a related procedure, the physician should monitor the patient for complications including excessive pain, bruising, discomfort, bleeding from the puncture site, stroke, or stroke-related symptoms. Any adverse effects related to a TVAM procedure should be reported to the FDA's MedWatch program.
FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction. FDA Safety Communications; March 8, 2017. www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm545286.htm. Accessed March 9, 2017.