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 Dr. Waleed Hassanein said in prepared remarks. “We are committed to continuing to drive medical innovation to make organ transplantation more successful and available for end-stage organ failure patients globally.”
Last November, the FDA told MassDevice.com that it decided it didn’t need to hold an advisory panel meeting to review the TransMedics heart preservation device. TransMedics is seeking an indication for “a portable, ex vivo organ perfusion system intended to preserve a donor heart in a near-normothermic and beating state from retrieval until the eventual transplantation into a suitable recipient,” according to the FDA.
In July, The Lancet published results from the Proceed II study of 130 heart transplant patients, who were randomized to receiving hearts preserved with the OCS or via cold static storage. The TransMedics device came up non-inferior for the trial’s primary endpoint of 30 day patient and graft survival compared with traditional cold storage (94% vs. 97%).
In a Lancet editorial, the authors pointed out that 5 donor hearts in the Proceed II OCS arm were found unacceptable for transplant and discarded, meaning they were also excluded from the recipient outcome-focused study – which could cut both ways.
“The investigators suggest that the Organ Care System was able to identify pathologically abnormal hearts, and that potential recipients of these hearts were spared exposure to suboptimum organs,” they wrote, noting that the OCS would be considered inferior if the endpoint were adequacy of myocardial protection and donor heart utilization “because hearts that were initially deemed acceptable for transplantation were ultimately not implanted.”
“Importantly, the pathological abnormalities identified in these hearts do not necessarily represent non-viability,” they wrote. “Therefore, if these hearts had been allocated to patients in the cold static storage group, they might well have been transplanted with a successful outcome.”
TransMedics raised $20 million last year for the OCS device.