Saturday, June 29, 2013

Responses to comments on our June Newsletter

As most of you know we have been negotiating with the FDA since their warning letter in May 2012 to get their approval to continue our Registry which had already enrolled over 400 MS patients receiving venoplasty.  In their most recent request for revisions they have asked that we add EDSS scores before and one year after the treatment.  We agree that this is an additional burden and that EDSS scores are incomplete and inaccurate. However, we have no choice and, at least ,in the United States these neurology evaluations should be covered by insurance.  We are aware that most insurance is presently not covering the venoplasty itself and patients will have to pay for this themselves.  We have approximately 6 IRs that have been waiting to begin doing the procedure again when we get approval. They are listed on our web site where you can also let us know if you might be planning to participate.

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