TransMedics Receives FDA Approval for its OCS Liver System for Preservation and Assessment of Donor Livers for Transplantation

Thursday, September 30, 2021

TransMedics Group, Inc., a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its OCS Liver System for use with organs from donors after brain death (DBD) and after circulatory death (DCD).

The OCS Liver System is indicated for the preservation and monitoring of hemodynamics and metabolic function which allows for ex-vivo assement of liver allografts from DBD and DCD donor livers. This indication is based on the results of the OCS Liver PROTECT Trial.

"We are extremely proud of this approval of our OCS Liver technology, as it represents the first and only liver perfusion technology to be approved by the FDA in the United States," said Waleed Hassanein, MD, President and Chief Executive Officer. "TransMedics is now uniquely 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."

"I am convinced that broad availability of warm extracoporeal donor liver perfusion will be the most important advance for the field of liver transplantation in decades," said Dr. James F. Markmann, Chief of the Division of Transplation Surgery at Massachusetts General Hospital and the Principal investigator of the OCS Liver PROTECT Trial. "The OCS Liver has the potential to save many lives by making liver transplants safer and by expanding the pool of available liver allografts."

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