FDA HAS APPROVED VENOPLASTY RESEARCH IN MS!
The next step is submission of the FDA documentation to the IRBs for each P.I. interventional radiologist. This will take several weeks. We will post the participating sites here. The FDA has allowed only 662 MS patients, only 10 interventional radiologists, has added a host of restrictions and safety guards. Unfortunately this registry is not a funded study, MSers will have to pay for the treatment. We will post the informed consent and other forms soon.
The Hubbard Foundation Multi-Center Registry for CCSVI Treatment and Follow-Up has enrolled and treated over 500 patients at over 20 interventional radiology sites across the United States. On May 10, 2012 the FDA issued a statement stopping all research on CCSVI until the FDA approves investigational device exemptions (IDE's). The Hubbard Foundation applied for this exemption immediately and had had several communications with the FDA; our most recent submission was sent May 3,2013. Once we receive the FDA's approval our interventional radiologists (IRs) will be able to begin enrolling and treating patients with vein obstructions again. Our IRs are among a small group of the most experienced in the CCSVI procedure, following a detailed protocol put together by input from all of them and discussed with the FDA.
Our study of the first 259 patients treated in San Diego by Doctors Ponec, Gooding and Saxon was published in the Journal of Vascular and Interventional Radiology in Sept 2012. This study found no serious adverse events and statistically significant improvement in symptoms using the Multiple Sclerosis Impact Scale. This study was not double-blind or placebo-controlled. Go to “Hubbard key papers” for the full print-out (pdf) of this study and others.