TransMedics Gets FDA Premarket Approval For Its OCS Liver System

TransMedics Group, Inc. (TMDX), a medical technology company, said on Wednesday that the U.S. Food and Drug Administration or FDA has granted premarket approval for its OCS Liver System for use with organs from donors after brain death or DBD and after circulatory death or DCD.

The OCS Liver System is indicated for the preservation and monitoring of hemodynamics and metabolic function which allows for ex-vivo assessment of liver allografts from DBD and DCD donor livers. This indication is based on the results of the OCS Liver PROTECT Trial, the Andover-based company said in a statement.

"TransMedics is now positioned to offer its OCS perfusion technology for lung, heart and liver transplantion. Our goal is to leverage these FDA approvals to make more donor organs available to help patients in need of the life saving transplant procedure. We are looking forward to expanding our commercial activities with all three OCS Systems starting in the fourth quarter of 2021," said Waleed Hassanein, MD, President and Chief Executive Officer.

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