Experimental Balloon Procedure Puts Patients at Risk

By MedTech Intelligence Staff

FDA has not approved the device for the procedure, called transvascular autonomic modulation.

An alert recently went out regarding an experimental procedure that uses balloon angioplasty devices outside the scope of the agency’s approved indications for use. Transvascular autonomic modulation involves the threading of a catheter into a patient’s venous system and inflating a balloon attached to the catheter in order to widen the vein walls. In this use, one physician has claimed the method treats the signs and symptoms of autonomic dysfunction in some neurological disorders. However, FDA has not reviewed data that supports the safe and effective use of balloon angioplasty devices for this approach.

Healthcare professionals and patients are encourage to report adverse events via the MedWatch Safety Information and Adverse Event Reporting Program.

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