Saturday February 24th 2018

FDA warns of off-label balloon angioplasty to treat autonomic disorders

The FDA today released a safety communication concerning risks associated with off-label balloon angioplasty procedures intended to treat autonomic dysfunction, warning of serious health risks and a lack of supporting data. The procedure, called trans venous autonomic modulation, involves a catheter being threaded into a patients’ venous system where an attached balloon is inflated to widen the vein walls. Physician Dr. Michael Arata claims the procedure can treat the signs and symptoms of autonomic dysfunction in a number of neurological disorders, according to the FDA. The federal watchdog warned of possible serious risks to patients from such procedures, with serious complications from such treatments being indicated in at least 1 death, blood clots in veins in the brain, cranial nerv…

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FDA warns of off-label balloon angioplasty to treat autonomic disorders

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