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.
This safety communication supplements a 2012 FDA safety communication and an FDA warning letter addressing the risk of serious injuries and death associated with a similar experimental procedure, using the same medical devices, to treat Chronic Cerebrospinal Venous Insufficiency (CCSVI).
Summary of problem and scope: 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, 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 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.
- TVAM and other similar experimental procedures have been associated with serious complications.
- After the safety communication issued in May 2012, the FDA received at least one medical device report of a balloon rupturing during placement in a patient’s jugular vein. Physicians ultimately determined the balloon had migrated to the patient’s lung, requiring surgery to remove the ruptured balloon.
- Other serious complications reported to the FDA or discussed in medical journals include: at least one death, blood clots in a vein in the brain (which may lead to a stroke), cranial nerve damage, and abdominal bleeding.
Studies of medical devices, such as balloon angioplasty devices, for use in autonomic dysfunction treatment, carry significant risk and require approval through an Institutional Review Board and the FDA’s Investigational Device Exemption (IDE) program. The IDE regulations help protect the rights, safety, and welfare of patients participating in these studies. The FDA is aware of at least one physician, Dr. Michael Arata, who 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.
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.
- 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.
- If any patients have experienced adverse effects from a TVAM procedure, please file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
For people with autonomic dysfunction, including but not limited to Parkinson’s disease, MS, fibromyalgia, multiple system atrophy, POTS, peripheral neuropathies, primary dysautonomia, and familial dysautonomia:
- Discuss the benefits and risks of all available treatments for autonomic dysfunction with your health care provider.
- If you decide to undergo diagnostic and/or experimental treatment procedures for autonomic dysfunction, continue following the treatment plan outlined by your neurologist or the provider caring for your symptoms related to autonomic dysfunction.
- Be aware that TVAM is an experimental procedure that has not been studied formally, 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.
- Be aware that 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.
- If you decide to undergo a TVAM procedure and then experience complications, contact your health care provider immediately. You may also file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
On September 13, 2016, the FDA issued a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letter to Dr. Arata for conducting a TVAM research study without the review and approval of the FDA. This letter is intended to inform the recipient clinical investigator that the FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving investigational products pursuant to FDA’s regulations. More information regarding the NIDPOE process can be found at FDA’s Clinical Investigators – Disqualification Proceedings site.
The FDA continues to monitor for adverse events related to medical devices (i.e. balloon angioplasty devices) used in experimental procedures for the treatment of symptoms associated with autonomic dysfunction, and will take action when appropriate.
The FDA will continue to monitor this situation and keep the public informed as new information becomes available.
Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect of a problem with angioplasty balloon devices, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.