The FDA is alerting doctors and 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.
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 of Newport Beach, CA, 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.
The FDA sent Dr. Arata a warning letter on September 5, 2012, after an FDA investigator found several serious violations of Title 21, Code of Federal Regulations (CFR) Part 812-Investigational Device Exemptions, and Part 50-Protection of Human Subjects. Violations included:
- Failure to submit an application to the FDA and obtain IRB and FDA approval prior to allowing subjects to participate in an investigation [21 CFR 812.20, 21 CFR 812.40, and 21 CFR 812.42]
- Failure to maintain accurate, complete, and current device shipment records [21 CFR 812.140(b)(2) and 21 CFR 812.140(d)].
- Failure to ensure that informed consent was obtained in accordance with 21 CFR Part 50 [21 CFR 50.27(a)].
- Failure to maintain accurate, complete, and current records related to your participation in the investigation [21 CFR 812.140(a)(2); 21 CFR 812.140(a)(3)(iii); and 21 CFR 812.140(d)].
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.
The FDA advised physicians:
- 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.
The MedWatch safety alert, including a link to the FDA Safety Communication is at https://www.fda.gov/Safety/