Cece wrote:My understanding is that medical devices are under the FDA umbrella, so if there were a new venous stent it would need to go through the FDA process, but that angioplasty itself is an already allowed procedure and further regulatory approval is not necessary for it.
So the course of action is: perform research (under IRB approval for patient protection); publish; other people perform complementary research and publish; IRs and neurologists everywhere read the published research and change their approach based on the findings.
fogdweller wrote:One addendum: After publication and approval by some important scientific group, the procedure might become "standard of care" so that every competent surgeon is supposed to try to apply this procedure. And that is not always based on huge studies. For example, inducing hypothermia in cardiac arrest patents became the standard of care after a study of only 56 patients.
drsclafani wrote:Dr. Scaflani, may I repeat my question which was probably lost between IBT Posts. Thank you.
I have a question:
Dr. Scaflani, is it true that some people have and some don`t have valves in jugular veins? It is said that you don`t need valves above your heart. I wonder what prevents people without valves to get reflux.
It is true that not all people have valves in the jugular veins. According to some autopsy results, about 15% of patients do not have valves in both jugular veins.
it is not true that all patients somehow do not get reflux, it is likely that there is reflux. reflux up the jugular vein transiently may not be a signficant problem most of the time, however there are reports of transient global amnesia (TGA) in patients with high pressure reflux.
OK, i cannot resist the opportunity to describe what TGA is NOT: it is NOT losing your way home while traveling around the world. It is a short term and intermittent episode of complete amnesia.
SofiaK wrote:Dr Sclafani:
Do all MS patients have vein narrowing? An MRV should show any narrowing, no?
I’m confused because I’m hearing different things.
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