336200login-checkFDA advisory committee unanimously agrees donor liver portable system is safe, effective |
“The FDA’s Gastroenterology and Urology Devices Panel, Medical Devices Advisory Committee voted unanimously that a portable system for near-normothermic continuous perfusion of donor livers with perfusate was safe and effective.
The system will be prepared by hospital pharmacy and include compatible packed red blood cells.
The panel addressed three questions related to the premarket approval of the device Organ Care System Liver System (TransMedics). The entire 14-member panel voted that the device is safe, all voted that the device is effective and voted 12 to 1 with 1 abstaining that the benefits of the OCS Liver System outweigh the risks.”
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336200login-checkFDA advisory committee unanimously agrees donor liver portable system is safe, effective |