TransMedics (NSDQ:TMDX) today announced that it has received FDA premarket approval for its OCS Liver system for use with organs from donors after brain death and circulatory death.
Andover, Massachusetts-based Transmedics designed the device to preserve and monitor the hemodynamics and metabolic function to allow for ex-vivo assessment of liver allografts from brain dead and circulatory dead donor livers.
“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,” president and CEO Waleed Hassanein said in a news release. “TransMedics is now uniquely positioned to offer its OCS perfusion technology for lung, heart and liver transplantation. 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.”
The FDA PMA was granted based on the results of the OCS Liver Protect trial. The system won FDA 510(k) clearance in July.
“I am convinced that broad availability of warm extracorporeal 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 transplantation 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.”