TransMedics Group has received full and unconditional investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its next-generation OCS ENHANCE Heart trial.
Part A of the trial will evaluate prolonged heart perfusion using the OCS Heart system while Part B will compare OCS Heart perfusion to static cold storage methods in donation after brain death (DBD) cases.
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The focus of Part B is to potentially expand clinical indications for OCS Heart to include standard criteria DBD hearts typically transplanted within four hours of preservation.
The total number of patients enrolled across both parts is anticipated to exceed 650.
TransMedics develops portable extracorporeal warm perfusion systems for donor organ assessment and preservation and has headquarters in Andover, Massachusetts, US.
The company’s technologies aim to maintain organ quality and viability pre-transplantation, supporting increased utilisation of donor organs for lung, liver, and heart failure.
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By GlobalDataTransMedics president and CEO Waleed Hassanein said: “Now that we have full and unconditional IDE approvals for both OCS ENHANCE Heart and DENOVO Lung trials, we are focused on trial execution and patient enrolment.
“The OCS ENHANCE Trial is the first of its kind to build the highest level of clinical evidence to hopefully demonstrate that the Gen 2 OCS Heart platform is more than a preservation technology, and can be used to enhance and improve cardiac function and metabolic conditions on the OCS System.
“Importantly, it will provide what we believe to be the first randomised, controlled, and blinded clinical trial in donor heart preservation to hopefully prove the superiority of the OCS Heart perfusion to cold static storage for heart transplantation. Outcomes of ENHANCE and DENOVO trials should serve as major catalysts for heart and lung adoption in 2026 and beyond.”
