FDA issues warning about risky vein opening procedure
TRENTON, N.J. (AP) — The Food and Drug Administration on Wednesday again warned patients and doctors to avoid a risky, experimental procedure promoted as a treatment for several nervous system disorders, including multiple sclerosis and Parkinson’s disease.
The procedure involves inflating a tiny balloon in narrowed veins, usually in the neck, to widen them and improve blood flow.
The FDA said it has seen no evidence the procedure — called transvascular autonomic modulation, or TVAM — is safe or effective. It’s similar to balloon angioplasty, which is commonly used to open up clogged heart arteries. Balloon angioplasty devices have not been approved for use in veins, the FDA said in the warning.
The FDA, which first warned against the procedure in 2012, said it has received one report of a balloon rupturing in a patient’s jugular vein and lodging in a lung. Other reported complications include at least one death, abdominal bleeding and blood clots and nerve damage in the brain.
The procedure was once touted and tried in the U.S., Italy and elsewhere to treat multiple sclerosis, a condition in which destruction of the protective coating of nerve fibers disrupts signals from the brain, causing problems with walking, vision, speech and memory.
On Wednesday, Canadian researchers reported the results of a study that tested the procedure in 104 MS patients. A year later, the patients who got the treatment fared no better than a group that got a sham treatment. The study of what some have called “liberation therapy” was led by researchers at the University of British Columbia and Vancouver Coastal Health, who presented the results at a medical meeting in Washington.
The procedure has also been promoted as treatment for other disorders, including fibromyalgia, damage to nerves, and other conditions related to the part of the nervous system that controls breathing, digestion, heart rate and other automatic body functions.
In its statement Wednesday, the FDA noted it has taken action against California physician, Dr. Michael Arata of Newport Beach, after warning him at least twice since 2012 that he was performing the experimental procedure on patients without approval to conduct a trial. Arata responded to the FDA’s initial warning that the agency had no jurisdiction over his work. The FDA’s case against Arata is pending. A call to Arata’s office seeking comment on Wednesday was not immediately returned.
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