Off-Label Use of Balloon Angioplasty Leads to Serious Risks. The U.S. Food and Drug Administration (FDA) just alerted physicians and the public concerning an experimental procedure known as an Transvascular Autonomic Modulation (TVAM). This procedure may place patients at increased risk and is being promoted as a treatment for an array of conditions despite that the procedure has not been officially studied in clinical trials. The TVAM procedure uses balloon angioplasty devices off-label, which means outside the scope of the FDA-approved indications for the device‘s use.
TVAM procedures involve threading a catheter into a patient’s venous system-the jugular vein, for example-in which a balloon attached to the catheter is inflated to widen the vein walls. At least one physician, Dr. Michael Arata of Newport Beach, California, says that the procedure treats the signs and symptoms of autonomic dysfunction in various neurological disorders. The FDA has not reviewed any data that supports the safety and efficacy of balloon angioplasty devices for this use.
In September 2012, the agency sent Dr. Arata a warning letter after an FDA investigator discovered a number of serious violations of Title 21, Code of Federal Regulations (CFR) Part 812-Investigational Device Exemptions, and Part 50-Protection of Human Subjects. The violations included:
- Failure to submit an application to the FDA and obtain Institutional Review Board (IRB) and FDA approval prior to allowing individuals 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 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 Dr. Arata’s participation in the investigation [21 CFR 812.140(a)(2); 21 CFR 812.140(a)(3)(iii); and 21 CFR 812.140(d)].
The FDA warns that it has neither cleared, nor approved, any balloon angioplasty devices for the treatment of autonomic dysfunction. The FDA also notes that it has not been presented with data to support the use of these devices in the treatment of autonomic dysfunction.
The FDA advised physicians to discuss the benefits and risks of all available treatments for autonomic dysfunction with their patients, including the adverse events that are typically tied to catheter-guided endovascular intervention and those related specifically to the use of balloon angioplasty devices for TVAM. Physicians are also advised to inform their patients that TVAM is experimental and that the agency has not been presented with any data to ensure the safety and efficacy of balloon angioplasty devices being used in this procedure. If a physician becomes aware of patients who have undergone the procedure, the patients should be monitored for potential complications, including excessive pain, discomfort, bruising, excessive bleeding from the puncture site, and stroke or stroke-like complications.
The product liability lawyers and personal injury attorneys at Parker Waichman LLP continue to offer free legal consultations to individuals with questions about filing a balloon angioplasty lawsuit.