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Thursday, May 17, 2012 10:04 PM | Ken Torbert Volg link

On May 10, the Food and Drug Administration issued a medical alert noting that individuals with
multiple sclerosis should be aware of the risks of serious injuries and death associated with treatments for
chronic cerebrospinal venous insufficiency—and that benefits of those treatments and promotion as an MS
treatment “may lead people with the disease to make treatment decisions without being aware of the serious
risks involved.”
As always, the Society of Interventional Radiology strongly urges close communications between
doctor and patient. Those persons with MS are encouraged to talk to their interventional radiologists
and their other doctors about any concerns or questions. SIR members—interventional radiologists
who specialize in minimally invasive targeted treatments and who pioneered venous angioplasty and
stenting—endovascular techniques that may be central to novel treatments for MS—may note an increase
in calls from concerned individuals who have—or are seeking—treatment for CCSVI.
About 500,000 people in the United States have MS, and SIR understands the public’s desire to
advance treatment for MS, generally thought of as an autoimmune disease in which a person’s body attacks
its own cells. Currently, medicines may slow the disease and help control symptoms. The role of CCSVI (a
reported abnormality in blood drainage from the brain and spinal cord) in MS and its endovascular
treatment (through a catheter placed in a vein to widen) by an interventional radiologist via balloon
angioplasty and/or stents to open up veins could be transformative for patients and is being actively
The FDA communication is directed toward individuals with MS, health care providers (including
interventional radiologists, neurosurgeons and vascular surgeons) and clinical investigators. Health care
providers were advised to inform patients that (1) there is conflicting evidence about CCSVI as a clinical
entity, (2) CCSVI’s relationship to MS is scientifically unproven and (3) consensus on the diagnostic
criteria of CCSVI has not been reached. The FDA also indicated that it has not cleared or approved any
angioplasty device or stents for CCSVI treatment and that the use of those devices in treating CCSVI is
considered off label. “While the FDA does not regulate the practice of medicine and health care
practitioners may choose to use a legally marketed device, based on their clinical assessment, for purposes
other than the cleared or approved use, the FDA believes the safety issues observed to date warrant a
communication on the subject,” stated the FDA announcement.
SIR supports and agrees with the FDA’s recommendations to encourage research on CCSVI and
the current knowledge regarding the safety and effectiveness of treatment procedures. SIR also
agrees that clinical research of CCSVI should be performed through well-designed clinical trials,
which should require approval through the FDA investigational device exemption (IDE) program.
In 2010, the SIR published the position statement “Interventional Endovascular Management of
Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis: A Position
Statement by the Society of Interventional Radiology, Endorsed by the Canadian Interventional
Radiology Association,” which specifically notes
SIR recognizes the urgent need for more effective treatments for MS patients and the public’s interest
in rapidly making such therapies available to this patient group.
SIR recognizes that patients with MS constitute a particularly vulnerable population, whose safety
must be protected as new therapeutic approaches are evaluated.
At present, SIR considers the published literature to be inconclusive on whether CCSVI is a clinically
important factor in the development and/or progression of MS and on whether balloon angioplasty
and/or stent placement are clinically effective in patients with MS.
SIR strongly supports the urgent performance of high-quality clinical research to determine the safety
and efficacy of interventional MS therapies and is actively working to promote and expedite the
completion of needed studies.
SIR recognizes the challenge and the potential opportunity presented by promising early studies of an
interventional approach to the treatment of MS. SIR is pleased that public advocacy groups have
pushed the medical community forward to meet this challenge and is committed to assuming a national
leadership role in launching needed efforts.
Interventional radiology is a recognized medical specialty requiring dedicated training that
encompasses clinical patient evaluation and management, non-invasive venous imaging and the delivery of
targeted, image-guided minimally-invasive treatments to patients. Interventional radiologists perform
balloon angioplasty and stent placements on a daily basis in thousands of patients with diverse venous
conditions, including acute deep vein thrombosis, post-thrombotic syndrome, superior vena cava syndrome
and portal hypertension; they also perform procedures to maintain hemodialysis access. Interventional
radiologists perform many of the CCSVI procedures in the United States; they are highly qualified to
perform such treatments when appropriately indicated.
SIR will provide additional information for patients as it becomes available