Categories | Lawsuits & Litigation Article

FDA Warns Against Using TVAM

March 21st, 2017 • Lawsuits & Litigation • 2 minute read
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Author Sara E. Teller

FDA Warns Against Using TVAM

The FDA is warning against using an experimental procedure, called transvascular autonomic modulation (or TVAM) as a treatment for nervous system disorders, such as multiple sclerosis and Parkinson's disease.  The treatment involves inflating a miniature balloon in narrowed veins, typically found in the neck, in order to widen them, therefore, improving blood flow. This helps reinvigorate the autonomic nervous system (ANS) by improving communication between the organs and the brain. The fairly new procedure has historically only been thought to help with if one has specific underlying conditions, and will not serve all patients with central nervous system disorders.  It is also based on the same principals as a procedure that was being utilized about a decade ago where people could have Vegas nerve stimulators put in. There is currently no insurance on the market that will cover TVAM, as it is experimental, not supported by the FDA, and is therefore, seen as unnecessary.

Image Courtesy of eL Aephau

Canadian researchers conducted a study led by the University of British Columbia and Vancouver Coastal Health testing the procedure on 104 patients with multiple sclerosis and found those receiving the treatment did not improve, and their condition was no better than those not receiving the treatment by the end of the study.  Many MS patients seemed to get temporary relief but symptoms came back after a few months or a year.In a statement submitted on Wednesday, the FDA indicated it was taking action against California physician Dr. Michael Arata of Newport Beach for using TVAM.  The administration had warned him on at least two occasions since 2012 that he was inappropriately using TVAM before receiving approval to conduct a trial.  Arata originally submitted a response stating that the FDA could not tell him what to do, as the agency has no jurisdiction over his work.  He refused to discontinue performing TVAM treatment on his patients, even after admitting he has found no explanation for how or why the procedure works for dysautonomia (nervous system dysfunction).  The case is currently pending.

Sources:

FDA issues warning about risky vein opening procedureWhat is the TVAM (Transvascular Autonomic Modulation) Procedure?
Sara E. Teller

About Sara E. Teller

Sara is a credited freelance writer, editor, contributor, and essayist, as well as a novelist and poet with nearly twenty years of experience. A seasoned publishing professional, she's worked for newspapers, magazines and book publishers in content digitization, editorial, acquisitions and intellectual property. Sara has been an invited speaker at a Careers in Publishing & Authorship event at Michigan State University and a Reading and Writing Instructor at Sylvan Learning Center. She has an MBA degree with a concentration in Marketing and an MA in Clinical Mental Health Counseling, graduating with a 4.2/4.0 GPA. She is also a member of Chi Sigma Iota and a 2020 recipient of the Donald D. Davis scholarship recognizing social responsibility. Sara is certified in children's book writing, HTML coding and social media marketing. Her fifth book, PTSD: Healing from the Inside Out, was released in September 2019 and is available on Amazon. You can find her others books there, too, including Narcissistic Abuse: A Survival Guide, released in December 2017.

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