"high fatalities"
Posted: Tue Feb 12, 2013 7:38 am
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There are safety studies showing jugular venoplasty to be a low risk procedure. The issue is that although the risk appears to be very low, there is not yet enough evidence in the medical literature to show that the benefit outweighs the risk.According to Dr. Lance Kim, a neurologist at the Florida Neurological Center in Ocala, “LDN has some promising results. It was originally used to treat narcotic addicts, but in low doses has a positive effect for MS patients. The CCSVI surgery tries to improve the drainage of the venous blood from the brain to the heart. It’s not approved by the FDA. It’s a high-risk procedure with high fatalities.”
Saying something is not FDA approved when it does not need to be FDA approved is misleading.You should be aware the FDA has not cleared or approved any angioplasty device or stents for the treatment of CCSVI and use of such devices in treating CCSVI are considered off-label at this time. 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.