FDA Issues Warning About Risky Vein Opening Procedure

The Food and Drug Administration is warning patients and doctors to avoid a risky, experimental procedure promoted as a treatment for nervous system disorders such as multiple sclerosis and Parkinson’s.

The procedure involves threading a balloon into veins in the neck and elsewhere to widen them and improve blood flow.

The federal agency said Wednesday it has seen no evidence the procedure – called transvascular autonomic modulation – is safe or effective. Balloon angioplasty devices have only been approved for use in arteries, the FDA said in the warning.

The FDA 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 and blood clots and nerve damage in the brain.

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