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Balloon angioplasty of the jugular vein -- dubbed transvascular autonomic modulation -- in an attempt to treat neurological disorders is not only experimental but carries serious risks, the .
The agency that a similar procedure to treat so-called chronic cerebrospinal venous insufficiency (CCSVI) carries serious risks, is not approved, and has no clear evidence of benefit. The vascular hypothesis for MS first proposed by Paolo Zamboni, MD, of the University of Ferrara in Italy has been largely debunked by a series of negative studies.
However, that hasn't stopped some proponents. The agency said the new warning was prompted by at least one physician broadening the list of neurological disorders he claimed to treat with transvascular autonomic modulation.
Michael Arata, MD, of Synergy Health Concepts in Newport Beach, Calif., has continued to conduct unauthorized clinical research using these devices despite a , the FDA noted.
The agency took the first step to block him from receiving investigational products in September 2016 for conducting a transvascular autonomic modulation research study without the review and approval of the FDA.
The FDA noted that balloon angioplasty devices are approved only for use in arteries, with no clear proof for safety and effectiveness in the venous system. Rather, there has been clear evidence of risk.
"After the safety communication issued in May 2012, the FDA received at least one medical device report of a balloon rupturing during placement in a patient's jugular vein. Physicians ultimately determined the balloon had migrated to the patient's lung, requiring surgery to remove the ruptured balloon," the FDA noted in the new safety notice.
"Other serious complications reported to the FDA or in medical journals include: at least one death, blood clots in a vein in the brain (which may lead to a stroke), cranial nerve damage, and abdominal bleeding."