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# FDA Airs Balloon Angioplasty Procedure Concerns
- URL: https://www.fdaweb.com/fda-airs-balloon-angioplasty-procedure-concerns/
- Published: 2017-03-08T12:00:00.000Z
- Updated: 2026-09-14T22:10:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138147

FDA has issued a safety communication to alert healthcare providers and others about its concerns with transvascular autonomic modulation, an experimental procedure using balloon angioplasty devices to treat autonomic dysfunction. The [communication](https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm545286.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says the procedure may put patients at risk because it is being promoted as treatment for a variety of conditions, even though it has not been formally studied in clinical trials. The procedure uses balloon angioplasty devices outside the scope of their approved indications for use, it says.

A 2012 safety communication addressed risk of serious injuries and death associated with a similar experimental procedure using the same devices to treat chronic cerebrospinal venous insufficiency, FDA says.

The agency says it has not reviewed any data supporting the safety and effectiveness of balloon angioplasty devices for transvascular autonomic modulation. The notice includes recommendations for doctors providing care and potential clinical investigators.