The FDA plans to convene an advisory panel to review the pre-market approval bid for the organ preservation device made by TransMedics.
The FDA’s Gastroenterology & Urology Devices panel is slated to meet Nov. 18 to discuss Andover, Mass.-based TransMedics’ PMA bid for its Organ Care System, which is designed to perfuse a donor heart with warm, oxygenated blood and monitor its status until transplantation.
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,” the federal safety watchdog said. Although it’s not bound by advisory panel recommendations, the FDA often follows their lead in its decisions.
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 over the summer for the OCS device.
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