FDA issues alert on use of angioplasty devices in TVAM

Editor's Note

The Food and Drug Administration (FDA) on March 8 issued a Safety Alert about the use of balloon angioplasty devices to perform an experimental procedure, called transvascular autonomic modulation (TVAM).

TVAM consists of threading a catheter into a patient’s venous system, such as the jugular vein, where a balloon attached to the catheter inflates to widen the vein walls. 

The FDA warned that it has not cleared or approved any angioplasty devices for the treatment of autonomic dysfunction and has not been presented with data to support the use of such devices for this treatment.

Posted 03/08/2017] AUDIENCE: Neurology, Surgery, Health Professional, Patient ISSUE: FDA is alerting the public about an experimental procedure called Transvascular Autonomic Modulation (TVAM). This procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials.