WSNS NEWS
FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients
The FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these experimental procedures have not been proven, and their promotion as a treatment for MS may lead people with the disease to make treatment decisions without being aware of the serious risks involved. The communication is also intended to notify physicians and clinical investigators planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices. The FDA sent a warning letter to a sponsor/investigator who was conducting a clinical study of CCSVI treatment without an approved IDE. Because the FDA currently considers clinical studies evaluating CCSVI treatment with balloon angioplasty devices and/or stents to be significant risk, this study was in violation of the FDA’s regulations. The sponsor/investigator has reported the study has been voluntarily closed.
See here for more information. (05/16/12)
From John W. Henson, MD, FAAN
MORE NEWS |
|
UPCOMING NEUROLOGY MEETINGS
New events coming soon!
WSNS PURPOSE
The purpose of this Society shall be:
- To promote the science and practice of neurology in Washington State;
- To advocate for neurologists and patients with neurologic disorders;
- To promote and protect the neurologic health of the public.
|
