On Sept 9th, 2012 we finally received an FDA response to our May 17th request for an evaluation of our on-going CCSVI Multi-center Registry.
The Agency has determined that our Registry is a “clinical study,” that we must submit to them an IDE (investigational device exemption) application, and that all enrollment of subjects must be suspended, although already enrolled subjects should continued to be monitored. Other main points are as follows:
· .
- Each individual device (balloon or stent) must be specified, including manufacturer.
· - The procedure and post-procedure (e.g. Use of blood thinners) must be standardized.
· - The diseases to be treated (e.g. multiple sclerosis, Parkinsons, Alzheimers, Migraine, Fatigue, Lyme disease) must be standardized.
· -The informed consent must be revised to emphasize risk of death (we have not had any).
· -In addition, the Agency made suggestions regarding our quality of life measure (SF-36vs) and the definition of “CCSVI.”
We plan to have a face-to-face meeting with the FDA and to discuss these recommendations with the IRs (interventional radiologists) participating in the Registry and hope to move forward quickly with an IDE application. In the meantime, the only IDE-approved study that may enroll CCSVI patients in North America is Dr. Siskin’s at Albany Medical College.