An FDA news release released recently says that people with multiple sclerosis (MS) are at risk of serious injuries and death when undergoing angioplasty to treat chronic cerebrospinal venous insufficiency (CCSVI). The FDA also asserted that the benefits of CCSVI treatment remain unproven.
The FDA said that although some people believe that CCSVI could cause MS or contribute to the progression of the illness, studies that examine this link are not conclusive, and the criteria for CCSVI diagnosis remain unsubstantiated.
The agency said there is not enough reliable evidence from controlled clinical trials that CCSVI treatment can alleviate the symptoms of MS.
“FDA encourages rigorously conducted, properly targeted research to evaluate the relationship between CCSVI and MS,” said William Maisel, M.D., M.P.H., the chief scientist and deputy director for science at 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.”
The CCSVI Alliance, a not for profit organization that promotes education and research about CCSVI and its relationship to Multiple Sclerosis (MS), responded by saying that the FDA has increased public awareness of CCSVI and that it was encouraging to see different responses from the Society of Interventional Radiology, the National Multiple Sclerosis Society and various medical professionals.
The CCSVI Alliance quoted Scott Johnson, the president and founder of the Myelin Repair Foundation, who said, “Medical research experts, like top scientists in all areas of high technology, must focus narrowly. But this kind of ‘siloing’ is a distinct disadvantage when it comes to complex diseases like MS. To solve multifaceted problems requires coordination among the most accomplished specialists in multiple disciplines.”
The CCSVI Alliance has been in dialogue with the FDA, suggesting there could be more collaboration and perhaps less premature condemnation on CCSVI in the future.
For information on CCSVI treatment at Angeles Health in Mexico, where we have a Stanford trained interventional cardiologist and neurologist working on every procedure and keep every patient in hospital for up to 5 days after their procedure, please contact us using the form on the right.