Got this over at Yahoo MB,comments?? Battelle contract goal is an IDE device for sepsis. by investa_gator1 • 15 minutes ago Flag If AEMD obtains the IDE FDA go ahead it would also support the Battelle contract goal for an IDE device for sepsis. That would be a real feather in their cap. The only thing holding the FDA back from granting any device IDE testing, is the assurance that any device is safe enough for use, FDA is 1 in 10 million use cycles. The biggest issue is how does the HP stop any of the fiber doping materials from entering the blood stream and that the delta pressures from the dialysis machines don't over pressure the HP device and cause failures. The HP filter should not have any problems if the dialysis machines operate properly. What measures has AEMD devised to insure that the over pressuring can not occur. This is an interesting problem.
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