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TransMedics launches pivotal trial for OCS liver transplant system
TransMedics said today that it launched a pivotal study of its OCS Liver device, which is designed to keep donated human liver warm and perfused until transplantation.
Andover, Mass.-based TransMedics said the 1st liver transplantation using OCS Liver was performed at Mass. General Hospital by Dr. James Markmann, a lead investigator for the 300-patient OCS Liver Protect trial and chairman of its steering committee.
“It is our hope that the ability to preserve a liver in the manner offered by the OCS technology will save lives by making the livers we use function better and by making more organs available for transplantation,” Markmann said in prepared remarks.
The OCS Liver Protect study is designed to compare liver transplantation using the TransMedics device with the standard of care – transplantation using a liver preserved on ice. Its primary endpoints are incidence of early liver allograft dysfunction at 7 days and incidence of liver graft-related serious adverse events at 30 days. Final data collection for the primary endpoint is slated for October.
“This is a significant milestone for TransMedics, as it represents the introduction of our 3rd product platform (in addition to our OCS Lung and OCS Heart platforms), and significantly expands our overall addressable market potential. It solidifies our market leadership position given that OCS is the only multi-organ platform in the market world-wide,” president &CEO ...