FDA Issues Alert Regarding Endovascular Treatment of CCSVI

May 10, 2012—The US Food and Drug Administration (FDA) issued a press release stating that the agency is alerting health care professionals and patients about injuries and death associated with the use of balloon angioplasty devices or stents to treat chronic cerebrospinal venous insufficiency (CCSVI), which some investigators hypothesize may cause or contribute to the progression of multiple sclerosis (MS) by impairing blood drainage from the brain and upper spinal cord. However, the FDA advised that studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.

According to the FDA statement, the agency has learned of death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage, and abdominal bleeding associated with the experimental procedure, in which balloon angioplasty devices or stents are used to widen narrowed veins in the chest and neck. Balloon angioplasty devices and stents are not FDA approved for treating CCSVI. 

Physicians and clinical investigators who are planning or conducting clinical trials using medical devices to treat CCSVI must comply with the FDA's regulations for investigational device exemptions, which are available on the FDA Web site. Complications following CCSVI treatment can be reported online through MedWatch. 

“Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, the FDA encourages rigorously conducted, properly targeted research to evaluate the relationship between CCSVI and MS,” commented William Maisel, MD, in the FDA press release, who is the Chief Scientist and Deputy Director for Science in the FDA's Center for Devices and Radiological Health. “Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes.”