CNClear wrote:Did anyone get to hold one of the stents? I did, and when I squeezed it, it sprung right back to its original shape and it seemed pretty indestructible given where it would be going...
I'm pretty sure Loobie said he stomped on one.
Yes, that is the property of memory metal. I've taken some of that stuff at work and heated it up with a cutting torch to red hot, it is very hard to change the properties of it, it always bounces back, just incredible stuff. But I'm not so sure when we talk of strictly tensile strength, that that is the only consideration here. Do I think they will fracture installed in veins, considering the amount of external stresses (vs. internal which is mostly the considerations of arterial stents) ? No, I don't really
think they will, even after being placed in a dynamic spot such as the neck, which gets (especially around the jaw area) a good amount of flexion and extension and movement in general, however, Radeck does make a good point of (and this is easy enough to envision), the edges causing welting and abrasion in general, which may or may not be deleterious to maintaining an uncompromised endothelial lining and could result in "callused" type skin forming at the interstitial (my fav. word) between man and machine.
Point being that these are VERY much unknowns at this point, and we DO need to keep in mind that these very stents are basically off-label at this point. I don't have to guess that there is nothing on the package that says, "approved for jugular use only". Yes that is bascially a spurious argument, in light of the fact that there are plenty of devices and especially medications that are used off-label, LDN being a prime example. Heck my GI doc when I had all that weird non-GI related nerve stuff going on last year related to bone spurs in my thoracic spine, prescribed a psychotropic drug of some form or another (can't recall but believe was an SSRI), with words to the effect of, "I know this is normally prescribed for xyz purposes, but take it anyway as it may help alleviate some of your symptoms" or words to that effect. Yeah it helped a little bit, and the problem was actually bone spurs in my middle back due to an old injury, which he couldn't have known at the time, point being of course, "this kind of off label usage for various drugs and/or devices happens all the time".
The problem of course begins if serious side effects begin to be noted, then the FDA or whoever gets involved. The prevalence of off label usage of various medications is so prevalent, it hardly warrants gasps of shock and incredulity. Wiki: http://en.wikipedia.org/wiki/Off-label_use
Of course we are talking medical devices here and not drugs. http://www.orthosupersite.com/view.asp?rID=41242
There's no "gotcha" here, since we aren't putting venous stents into fingers and calling them "finger braces" to exaggerate the example. They're still going in veins, but whether the specific ones used are "specifically made for jugular veins", can be argued as being irrelevant, for obvious reasons, a vein is a vein is a vein.
The devices in question are FDA approved. That's important here. Non-FDA used off label can get you in trouble.
I'd call your attention to this paragraph in the article linked above:
Remember, you are not allowed to use a non-FDA approved product without further regulatory approval and … you are not allowed to use any devices on or off label when your primary interest is to test a hypothesis or obtain generalized results unless you have an appropriately approved research protocol. That is a study. That is different,” he noted.
That's some food for thought....