FDA Issues Warning over CCSVI Treatment

The FDA is notifying 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.

The US FDA has alerted healthcare professionals and patients about an unproved treatment for chronic cerebrospinal venous insufficiency (CCSVI), which has been linked to serious injuries and death.

CCSVI, which is characterised by a narrowing of veins in the neck and chest, has been said to cause multiple sclerosis or contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord. The experimental procedure, known as 'liberation therapy', uses balloon angioplasty devices or stents to widen the narrowed veins.

The FDA received reports in 2011 of a patient who died from bleeding in the brain after undergoing the treatment and another who was left permanently paralysed by a stroke.