Venous intervention for treatment of CCSVI in multiple sclerosis

By Frank J. Criado, MD, FACS, FSVM

The FDA issued a press release on May 10, 2012 alerting physicians and patients about injuries and death associated with the use of balloon angioplasty or stenting to treat chronic cerebrospinal venous insufficiency (CCSVI), which some experts suspect may cause or contribute to the progression of multiple sclerosis (MS) by impairing blood drainage from the brain and proximal spinal cord. The FDA emphasized that studies exploring a link between MS and CCSVI are inconclusive, and that the criteria used to diagnose CCSVI have not been established.

According to their statement, the FDA has learned of death, stroke, detachment and migration of stents, damage to the treated vein, blood clots, cranial nerve damage, and abdominal bleeding associated with the experimental procedure. “Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, the FDA encourages rigorously conducted, properly targeted research to evaluate the relationship between CCSVI and MS,” commented William Maisel, MD, in the FDA press release.Dr. Maisel is the Chief Scientist and Deputy Director for Science in the FDA’s Center for Devices and Radiological Health.

This is an important issue in light of recent unsupported claims of effectiveness for these procedures and the proliferation of such venous interventions performed in various parts of the country and around the world.

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Venous intervention for treatment of CCSVI in multiple sclerosis

By Frank J. Criado, MD, FACS, FSVM

The FDA issued a press release on May 10, 2012 alerting physicians and patients about injuries and death associated with the use of balloon angioplasty or stenting to treat chronic cerebrospinal venous insufficiency (CCSVI), which some experts suspect may cause or contribute to the progression of multiple sclerosis (MS) by impairing blood drainage from the brain and proximal spinal cord. The FDA emphasized that studies exploring a link between MS and CCSVI are inconclusive, and that the criteria used to diagnose CCSVI have not been established.

According to their statement, the FDA has learned of death, stroke, detachment and migration of stents, damage to the treated vein, blood clots, cranial nerve damage, and abdominal bleeding associated with the experimental procedure. “Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, the FDA encourages rigorously conducted, properly targeted research to evaluate the relationship between CCSVI and MS,” commented William Maisel, MD, in the FDA press release.Dr. Maisel is the Chief Scientist and Deputy Director for Science in the FDA’s Center for Devices and Radiological Health.

This is an important issue in light of recent unsupported claims of effectiveness for these procedures and the proliferation of such venous interventions performed in various parts of the country and around the world.

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