Because neither MRV nor ultrasound has adequate sensitivity and specificity to be diagnostic, for our Registry FDA application, we are not requiring either of those tests. We are encouraging IVUS(intravenous ultrasound) which can be done at the same time as catheter venography which remains the gold standard. We hope to hear from the FDA within the month about restarting testing and treatment.
We've been encouraging IVUS here at TiMS for quite some time! I think IVUS is getting more mainstream than what it was. Great news.
We expect a response from the FDA regarding the Hubbard Foundation's request for an IDE for our Multi-Center Registry in early February 2013. The FDA had acknowledged our complete submission on January 6,2013 and has 30 days to respond. Based on their initial response in September 2012 we are cautiously optimistic.
Should know soon if their registry will be FDA approved and back in business.
C-Reactive Protein (CRP) and MS. Here's an abstract from a 2005 paper. http://www.ncbi.nlm.nih.gov/pubmed/16009907 We have become interested in the measure of serum high sensitivity C-reactive protein (HS-CRP) as the best measure available for monitoring low grade inflammation in the blood stream. We think one of the common denominators between CCSVI and MS is inflammation at the blood brain barrier (BBB). We believe that one can significantly decrease inflammation with diet. For instance, Arlene had a CRP of 9 and reduced it to .1 after being on a gluten free, modified Paleo diet. ( normal is considered 1-3 mg/L). This 2005 paper published in Neurology is one of the few papers linking CRP to MS. It showed that CRP was higher during relapses and was reduced by interferon treatment;everyone should have their CRP tested routinely and should consider dietary methods to reduce inflammation.
I posted more from the newsletter than I normally would but there was a lot of good information in there.
Here's the link to where you can sign up for the newsletter if interested: http://www.hubbardfoundation.org/ccsvi-education