Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued safety alerts concerning an experimental procedure called Transvascular Autonomic Modulation (TVAM). This 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 TVAM procedure is also outside the scope of the FDA-approved indications for the use of balloon angioplasty devices. 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 procedure has been claimed to treat 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.

The FDA believes that performing a TVAM procedure using these medical devices poses a risk to patients because:

• The safety and effectiveness of using balloon angioplasty devices in a patient's venous system has not been established for any clinical condition. The FDA has approved these devices for use only in arteries.
• There is no clear scientific evidence to support that the treatment of internal jugular venous stenosis:
  • is safe in any patients, including those with autonomic dysfunction;
  • impacts the symptoms of autonomic dysfunction;
  • changes the overall course of health conditions derived from autonomic dysfunction; or
  • improves the quality of life for patients with autonomic dysfunction.
• Serious complications such as excessive pain, discomfort, bruising or excessive bleeding from the puncture site can occur after a TVAM procedure. Complications can also include stroke, or stroke-like symptoms.

Health professionals and people with autonomic dysfunction should refer to the specific recommendations on the FDA's websites:
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm545286.htm
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm545619.htm

Posted on 9 March 2017