Off-Label Use of Balloon Angioplasty Devices 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.
Balloon Angioplasty and Atherosclerosis
According to MedicineNet.com, a balloon angioplasty, also known as a coronary angioplasty, utilizes a balloon-tipped catheter that is inserted through an artery in the groin or arm to enlarge a narrowing in a coronary artery.
Coronary artery disease occurs when cholesterol plaque accumulates, which is known as atherosclerosis, in the walls of the arteries to the heart. Angioplasty is known to be successful in opening coronary arteries in about 90 percent of patients; however, 40 percent of patients who undergo a successful coronary angioplasty will develop recurrent narrowing at the site of balloon inflation. This procedure is now only rarely performed without also placing a stent in the artery.
WebMD explains that hardening and narrowing of the arteries (atherosclerosis) that slowly blocks arteries, placing blood flow at risk. Atherosclerosis is the typical cause cardiovascular disease, which involves heart attacks, strokes, and peripheral vascular disease. Peripheral artery disease is a narrowing that occurs in the arteries of the legs due to plaque that causes poor circulation and makes walking painful. Peripheral artery disease also causes wounds to not heal well and, when severe, may lead to the need for amputation.
Arteries are blood vessels that are responsible for carrying blood from the heart throughout the body. Arteries are lined with a thin layer of cells that are known as the endothelium, according to WebMD. The endothelium is responsible for keeping the interior of arteries toned and smooth, which keeps blood flowing. Atherosclerosis starts when the endothelium becomes damaged and is typically caused by high blood pressure, smoking, or high cholesterol. The damage leads to plaque formation.
When bad cholesterol, known as low-density lipoprotein or LDL, crosses the damaged endothelium, cholesterol enters the wall of the artery, causing white blood cells to flow in to digest the LDL. Over years, the cholesterol and cells become plaque in the arterial wall. Plaque, in turn, creates a bump on the artery wall, which increases as atherosclerosis progresses. When the bump enlarges, it may create a blockage. A process that continues throughout the body, placing the body at significant risk for heart attack and stroke. Atherosclerosis does not typically cause symptoms until middle age or older. And, as the narrowing becomes severe, blood flow is choked off, causing pain. Blockages may also rupture, causing blood to clot within an artery at the site of the rupture, according to WebMD.
Plaque from atherosclerosis may remain in the artery wall, growing to a certain size and stopping. This plaque does not block blood flow and may never cause symptoms. Plaque may also grow slowly and in a controlled way into the blood flow path, eventually leading to significant blockages. Typical symptoms include pain in the chest or legs when the individual exert himself or herself. In the worst case, plaque ruptures, allowing blood to clot within an artery. When this occurs in the brain, a stroke occurs. When this occurs in the heart, a heart attack occurs.