In Reply to: Case 0298_11--Infrarenal abdominal aortic traumatic rupture: Treatment with endoluminal covered stent posted by Editor on February 06, 1998 at 09:13:02:
Beautiful case, nicely illustrated. I am going to weigh in as the devil's advocate here. We have absolutely no idea what the long-term results of this or any other device will be and in a 35 year old woman I suspect this will cause trouble of some sort down the road. While I think it is reasonable to pressure the FDA to take a close look at these devices, we also need to be cognizant of their role in determining SAFETY not efficacy.
The nice thing about this case is it was done as part of an FDA approved clinical trial, albeit for a non-trial application. Interestingly a second Wallgraft trial is now starting for this specific application, perhaps Schneider got the message from your trauma cases that it was worth pursuing full approval for trauma/aneurysms.
As one of the few sites using this device, have you seen any down side to it?