The FDA ( Food and Drug Administration ) has alerted health care professionals and patients about injuries and death associated with the use of an experimental procedure to treat chronic cerebrospinal venous insufficiency ( CCSVI ).

Some researchers believe that CCSVI, which is characterized by a stenosis of veins in the neck and chest, may cause multiple sclerosis or may contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord. However, studies exploring a link between multiple sclerosis and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.

The experimental procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. However, the FDA 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. Balloon angioplasty devices and stents have not been approved by the FDA for use in treating CCSVI.

The FDA has also notified physicians and clinical investigators who are planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices. Any procedures conducted are considered significant risk clinical studies and require FDA approval, called an investigational device exemption.

Source: FDA, 2012

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