FDA MedWatch -Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures

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. The procedure uses balloon angioplasty devices outside the scope of the FDA-approved indications for use.
BACKGROUND: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. At least one physician, Dr. Michael Arata, claims the procedure treats the signs and symptoms of autonomic dysfunction in a number of neurological disorders. The FDA has not reviewed any data that supports the safety and effectiveness of balloon angioplasty devices for this intended use.
 
RECOMMENDATION:For physicians providing care and potential clinical investigators: Be aware that the FDA has not cleared or approved any balloon angioplasty devices for the treatment of autonomic dysfunction, and has not been presented with data to support the use of such devices in treating autonomic dysfunction. Discuss the benefits and risks of all available treatments for autonomic dysfunction with patients, including the adverse events generally associated with catheter-guided endovascular intervention and those related specifically to use of balloon angioplasty devices for TVAM. Inform patients that TVAM is experimental, and that the FDA has not been presented with any data in order to assure the safety and effectiveness of balloon angioplasty devices used in this procedure. If you become aware of patients who have undergone the procedure, monitor them for potential complications such as excessive pain, discomfort, bruising, excessive bleeding from the puncture site, and stroke or stroke-like complications.
Read the FDA Safety Communication for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Safety Communication athttps://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm545619.htm