CCSVI Alliance has been notified of the FDA's concerns. We agree that the Investigational Device Exemption (IDE) regulations help ensure that the rights, safety and welfare of patients are protected during studies and that the risks are as low as possible and are balanced by any potential benefits. We will keep you apprised of this situation.


FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis
www.fda.gov
Warning about Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients