The FDA is asking for compliance in using catheters and balloons in an off-label venous situation. The problem is that these tools are used everyday in the veins of people around the world, even though they are technically only approved for use in arteries. This is the first time the FDA has intervened in the usage of PTA in veins. Dr. Arata's comment is true, but rather confrontational.
The FDA is asking for reports on adverse affects. The Hubbard Foundation, who were interviewed for this Reuters piece, but not quoted (as well as CCSVI Alliance, Drs. Siskin and Dr. Mehta) is complying with the FDA and compiling a list of adverse affects reported NOT ONLY by their registry, but from others. A rather daunting task, but they are doing it because they want to comply with the FDA's request. This is from the Hubbard Foundation blog:
As you know on Sept 11 we finally received the FDA’s response to our request for approval to continue our research. The IDE guidelines call for a listing of complications and adverse events both from the published literature and from non-published sources such as newspaper stories and the internet. We would like to be very thorough with this. So we are asking all of you to share with us any adverse events you had yourself or know about. We will just list dates, not names of course. If it is a “serious” adverse event, e.g. death or hospitalization, we will try to give additional information if you all can help provide it. For instance we are only aware of three deaths, does anyone have any details on these, and is anyone aware of other deaths?
This is very important progress. We expect the FDA will give us the green light, that this will open the door for Americans finally and we hope every patient will be counted.
Sadly, the Reuters reporter chose to focus on the one center that is not complying, rather than speak to those who are working with the FDA in due diligence (Siskin, Mehta, BNAC, Hubbard Foundation, etc) It's a problem in the US media, and the focus continues to be on controversy, rather than published research. BNAC is presenting research at ECTRIMS next week which showed increased cerebrospinal fluid movement in ALL 15 people with CCSVI who were treated with venoplasty. CSF stasis is a known component of neurodegeneration, and was improved with venoplasty. Why is this not the story? Your guess is as good as mine, horizon.http://registration.akm.ch/einsicht.php ... KEN_ID=900