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 the publication of OCS™ Liver PROTECT Trial Results in JAMA Surgery, a member of the Journal of the American Medical Association (JAMA) Network. The publication, titled Impact of Portable Normothermic Blood-Based Machine Perfusion on Outcomes of Liver Transplant, was published online on January 5, 2022. The OCS™ Liver System was approved by the U.S. Food and Drug Administration (FDA) for the preservation and assessment of donor livers for transplant from donors after brain death (DBD) and after circulatory death (DCD) on September 29, 2021.
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“The PROTECT trial showed superior short-term and mid-term clinical outcomes and higher numbers of donor livers used for transplant,” said Dr. James F. Markmann, Chief of the Division of Transplantation Surgery at Massachusetts General Hospital and the lead author of the manuscript. “We concluded, that the advent of portable, extracorporeal, donor liver machine perfusion offers for the first time a convenient and effective approach to both clinically assess and enhance donor liver function, thereby improving transplant safety, expanding the liver donor pool, and reducing waiting list mortality – This is a game changer in liver transplantation.”
“We believe these superior clinical results represent a groundbreaking milestone for liver transplantation,” said Waleed Hassanein, MD, President and Chief Executive Officer. “This publication is further evidence that the OCS Liver System along with our OCS Lung and OCS Heart Systems will significantly improve patient outcomes and expand the pool of eligible donors, thereby saving more lives.”
About the OCS™ Liver PROTECT Trial
The OCS™ Liver PROTECT Trial was a two-armed, multicenter, prospective, randomized, controlled pivotal trial to evaluate the effectiveness and safety of the OCS™ Liver to preserve and assess donor livers intended for transplantation. The trial enrolled 300 patients, with 153 patients randomized to transplantation using the OCS™ Liver and 147 patients randomized to the control group, which used cold storage methods. Enrollment was completed in October 2019 with transplants conducted across a network of 20 major liver transplant centers in the U.S.
The primary effectiveness endpoint for the study was the incidence of EAD in the first 7 days following transplant procedures. The primary safety endpoint for the study was the average number of liver graft related serious adverse events (SAEs) per patient measured over 30 days following transplant procedures. The study also measured the rate of DCD & DBD donor utilization, the incidence of ischemic biliary cholangiopathy, and other clinical endpoints throughout the first year after liver transplantation.
The study results demonstrated that the primary effectiveness end point was met by a significant decrease in EAD (27 of 150 [18%] vs 44 of 141 [31%]; P = .01) and that the OCS™ Liver preserved livers had significant reduction in histopathologic evidence of ischemia-reperfusion injury after reperfusion (eg, less moderate to severe lobular inflammation: 9 of 150 [6%] for OCS™ Liver vs 18 of 141 [13%] for ischemic cold storage (ICS); P = .004). The OCS™ Liver resulted in significantly higher use of livers from donors after cardiac death (28 of 55 [51%] for the OCS™ Liver vs 13 of 51 [26%] for ICS; P = .007). The OCS™ Liver was also associated with significant reduction in incidence of IBC 6 months (1.3% vs 8.5%; P = .02) and 12 months (2.6% vs 9.9%; P = .02) after transplant.
About TransMedics Group, Inc.
TransMedics is the world’s leader in portable extracorporeal warm perfusion and assessment of donor organs for transplantation. Headquartered in Andover, Massachusetts, the company was founded to address the unmet need for more and better organs for transplantation and has developed technologies to preserve organ quality, assess organ viability prior to transplant, and potentially increase the utilization of donor organs for the treatment of end-stage heart, lung, and liver failure.