The FDA’s Gastroenterology and Urology Devices Panel, after a review and discussion, issued a favorable vote in support of approval of TransMedics Group’s (NASDAQ:TMDX) OCS Liver System.
The panel voted 14-to-0 that there is reasonable assurance that the OCS Liver System is effective and 14-to-0 that there is reasonable assurance of the OCS Liver System’s safety. The panel voted 12-to-1, with one abstaining that the benefits of the OCS Liver System outweigh its risks.
“The OCS Liver PROTECT trial demonstrated that OCS Liver has the ability to provide superior clinical outcomes and improve utilization of donor livers for transplantation,” lead investigator, Dr. James Markmann, said in a statement. “This is truly a game-changer in the field of liver transplantation.”
Dr. Markmann said the OCS Liver System allows surgeons to both assess and enhance donor liver function before transplantation, which can improve transplant safety and enables the use of donor livers that would otherwise go unused. “If approved by the FDA, I believe the OCS Liver will allow us to provide more life-saving transplants for patients with end-stage liver disease,” he added.
Dr. Waleed Hassanein, president and CEO of TransMedics, said the FDA panel vote “brings us closer to potentially having all three OCS products FDA approved and commercially available in the U.S. for lung, heart and liver transplantation.”
The company’s OCS Lung System is approved in the U.S., and the OCS Heart System is currently under review by the FDA after receiving a positive vote by the FDA’s Circulatory System Device Advisory Panel in April.