The U.S. Food and Drug Administration (FDA) has granted full and unconditional investigational device exemption (IDE) approval to TransMedics Group for its next-generation OCS ENHANCE Heart trial, a development that could reshape how donor hearts are preserved and assessed.
A Two-Part Approach to Heart Preservation
The trial is structured in two parts. Part A will focus on evaluating prolonged heart perfusion using the OCS Heart system. Part B will directly compare OCS Heart perfusion to traditional static cold storage methods in cases of donation after brain death (DBD).
What’s the goal? The focus of Part B is to potentially broaden the use of OCS Heart to include standard criteria DBD hearts typically transplanted within four hours of preservation.
Researchers anticipate enrolling over 650 patients across both parts of the trial, making it a substantial undertaking in the field of cardiac transplantation.
Beyond Preservation: Enhancing Organ Viability
TransMedics, headquartered in Andover, Massachusetts, develops portable extracorporeal warm perfusion systems designed for both donor organ assessment and preservation. Their technologies are intended to maintain organ quality and viability before transplantation, ultimately supporting increased utilization of donor organs for patients suffering from lung, liver, and heart failure.
“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,” said Waleed Hassanein, president and CEO of TransMedics.
Hassanein explained that the OCS ENHANCE Trial is unique, aiming to establish robust clinical evidence demonstrating that the Gen 2 OCS Heart platform isn’t merely a preservation technology. Instead, it could actively enhance and improve cardiac function and metabolic conditions while 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,” Hassanein added. “Outcomes of ENHANCE and DENOVO trials should serve as major catalysts for heart and lung adoption in 2026 and beyond.”
