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 nerve damage and abdominal bleeding. While the safety and effectiveness of angioplasty procedures were tested in arteries, they were not tested in patients’ venous systems, according to the FDA. In addition, a clear lack of scientific evidence exists showing that the treatment is safe, positively impacts symptoms or health conditions or improves the quality of life for patients with autonomic dysfunctions. The warning comes the same day that new data emerged showing that similar venoplasty procedures in the brain and spine have no effect on treating patients with multiple sclerosis. Researchers, led by the University of British Columbia and Vancouver Coastal Health, sought to explore the effec...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Catheters Food & Drug Administration (FDA) Neurological Source Type: news