FDA: Balloon Angioplasty Devices Not Approved for Venous System

Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Experimental Transvascular Autonomic Modulation (TVAM) Procedure Poses Risks

Balloon angioplasty is a procedure commonly used in patients with atherosclerosis, when the arteries become hardened and narrowed. Doctors insert a catheter into the artery and inflate a balloon attached the tip. The inflated balloon widens the artery and improves blood flow. The U.S. Food and Drug Administration (FDA) has only approved balloon angioplasty for use in the arteries, not the veins. The agency recently issued a Safety Communication warning against the use of balloon angioplasty devices in the venous system.

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In a Mar. 8 Safety Communication, regulators cautioned that use of balloon angioplasty devices in the venous system could pose serious risks to patients. The agency said it was aware of at least one physician promoting this use in an experimental procedure known as Transvascular Autonomic Modulation (TVAM). The FDA warned that there is no clinical trial data to show that this is procedure is safe or effective.

At least one physician claims that TVAM is effective at treating symptoms of autonomic dysfunction in patients with various neurological disorders, including Parkinson’s disease, multiple sclerosis (MS), fibromyalgia, multiple system atrophy, postural tachycardia syndrome (POTS), peripheral neuropathies, primary dysautonomia, and familial dysautonomia. The safety alert cautions, however, that “The FDA has not reviewed any data that supports the safety and effectiveness of balloon angioplasty devices for this intended use,”

“The safety and effectiveness of using balloon angioplasty devices in a patient’s venous system has not been established for any clinical condition.”

Regulators emphasize that there is no evidence to show that this procedure is safe, improves symptoms of autonomic dysfunction, or improves quality of life. There is no evidence to suggest that use of balloon angioplasty for internal jugular venous stenosis improves health conditions related to autonomic dysfunction.

Using balloon angioplasty devices in the venous system presents risks to patients. These products have not been tested or approved for use in the veins, which are much thinner than arteries. Arteries are the large, thick-walled blood vessels transporting blood away from the heart while veins return blood back to the heart from body tissues.

The FDA has warned of serious, fatal complications associated with using balloon angioplasty devices in the venous system in the past. Studies of certain medical devices, including balloon angioplasty devices, must be approved through an Institutional Review Board and the FDA’s Investigational Device Exemption (IDE) program because these devices carry significant risk to patients. The physician named in the Safety Communication “has continued to conduct unauthorized clinical research using these devices. The expanded list of neurological disorders he claims to treat warrant an update to the 2012 safety communication on the subject,” the alert states.

FDA Warning Letter Cites Serious Injury and Death Related to Experimental Balloon Angioplasty Procedure

In 2012, the FDA warned against experimental procedures using balloon angioplasty devices to treat chronic cerebrospinal venous insufficiency (CCSVI) in patients with multiple sclerosis (MS). The agency issued a warning letter and a Safety Communication cautioning that “the benefits of these experimental procedures have not been proven, and their promotion as a treatment for MS may lead people with the disease to make treatment decisions without being aware of the serious risks involved.” Additionally, the relationship between MS and CCSVI is unclear, the FDA said.

The experimental CCSVI treatment is also known as “liberation therapy” or the “liberation procedure.” Balloon angioplasty or stents are used to widen the narrowed internal jugular or azygos veins.

“CCSVI procedures have been associated with serious, even fatal, complications,” the notification warns. “The FDA has received reports of one patient who died from bleeding in the brain and one patient who suffered permanent paralysis from a stroke after CCSVI treatment.”

The FDA has received reports of at least one death, blood clots in a vein in the brain, cranial nerve damage, and abdominal bleeding associated with experimental CCSVI treatment. Regulators also cite one case where a balloon ruptured as it was being placed into a patient’s jugular vein. The ruptured balloon migrated to the patient’s lung, and was surgically removed.

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