Human HD WAK Trials Reported at ASN
The FDA requires “proof of concept” trials, and Dr. Victor Gura’s 10-lb. HD wearable artificial kidney has passed its first one. Seven patients wore the WAK for 24 hours, with no adverse events and consistent ultrafiltration rates. Malfunctions such as tubing leaks, CO2 bubbles in the dialysate, and variable blood and dialysate flow rates stopped the trial, and the WAK, fast-tracked by the FDA, will be redesigned before it is tested again.
Read the full article » | Posted 11/11/2015
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