Friday, 11 May 2012

FDA Safety Communication CCSVI

FDA Safety Communication: Chronic Cerebrospinal Venous Insufficiency Treatment in Multiple Sclerosis Patients

The FDA today issued a safety communication about CCSVI
This announcement follows on from a similar announcement from NICE in UK. As many of our readers are based in USA the announement is worth a read. Although we have talked about most of the points on the blog. I would draw your attention to advice about any one wanting to and undertaking the procedure.

Audience: People with multiple sclerosis (MS), their families and caregivers; Neurologists; Interventionalists (Radiologists, Vascular Surgeons and Neurosurgeons); Clinical Researchers; other MS health care providers; and Institutional Review Boards (IRBs).

For People with Multiple Sclerosis:
Be aware that there is lack of clear evidence of the existence of CCSVI. Furthermore, the link between CCSVI and MS and the safety and effectiveness of the CCSVI treatment procedure in MS patients has not been established.



You should know that serious complications can occur as a result of CCSVI treatment procedures. Before you have any CCSVI procedure, discuss with your physician or other health care provider the signs and symptoms of such complications. Before considering CCSVI treatment, discuss the potential risks and benefits with a neurologist or other health care provider who is familiar with MS and CCSVI (including the CCSVI procedures and their outcomes). If you undergo treatment for CCSVI and experience a complication, we encourage you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

As some of you may know that one of the trials on CCSVI has been recently terminated. The reason for this may be found in the FDA notice (see below)

The FDA has determined that investigations of medical devices for use in CCSVI treatment are significant risk studies. Clinical studies of significant risk medical devices, such as in the case of balloon angioplasty devices and stents to treat CCSVI, require approval through an IRB and the FDA’s Investigational Device Exemption (IDE) program. The IDE regulations help ensure the rights, safety and welfare of patients are protected during these studies and that the risks are as low as possible and are balanced by any potential benefits.

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.

This is not research hence the post,