TransMedics Earns FDA IDE Nod for Next-Gen OCS Heart ENHANCE Trial

TransMedics revealed that the U.S. Food and Drug Administration (FDA) approved its IDE for the next-gen OCS ENHANCE Heart trial. This follows FDA approval of the company’s next-gen OCS DENOVO Lung IDE trial last month and conditional IDE approval for the ENHANCE Heart trial in August 2025.

The ENHANCE trial is a two-part clinical trial. Part A is designed to support prolonged heart perfusion using OCS Heart System. Part B is intended to demonstrate the superiority of OCS Heart perfusion in donation after brain death (DBD) cases when compared to DBD cases using static cold storage methods.

Part B is intended to support the potential expansion of OCS Heart clinical indications to include standard criteria DBD hearts that are currently transplanted within 4 hours of preservation. The trial’s total sample size, across both Part A and Part B, is expected to exceed 650 patients.

“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 enrollment,” said Waleed Hassanein, MD, TransMedics’ president and CEO. “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 randomized, 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.”