FDA Panel Votes In Favor Of TransMedics' OCS Liver System

(RTTNews) - TransMedics Group Inc. (TMDX) said Wednesday that the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee convened by the U.S. Food and Drug Administration has issued a favorable vote in support of approval of the OCS Liver System.

"Today's 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," said Waleed Hassanein, President and Chief Executive Officer.

The FDA panel voted 14 to 0, in support of the OCS Liver System's safety and effectiveness. The panel voted 12 to 1, with 1 abstaining, that the benefits of the OCS Liver System outweigh its risks.

The 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.