FDA Grants FDA IDE Approval for TransMedics OCS Heart Trial

TransMedics Group Inc. has earned U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to begin its next-generation OCS ENHANCE Heart trial.

The ENHANCE study 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 also aims to support the potential expansion of OCS Heart clinical indications to include DBD hearts that are not currently eligible for OCS perfusion and preservation. The study’s total sample size across both Part A and Part B is expected to exceed 650 patients. According to TransMedics, the study would constitute the largest ever conducted worldwide for heart preservation for transplant.

“The recent FDA approvals to initiate our next-gen OCS ENHANCE Heart and DENOVO Lung trials mark key milestones in our ongoing commitment to transforming the standard of care and address the major clinical needs of the cardiothoracic transplant community,” TransMedics Group President/CEO Waleed Hassanein, M.D., said. “We are thrilled to be in a position to initiate both trials in the fourth quarter of 2025 while we continue to work collaboratively with the FDA to address any remaining questions related to pre-clinical testing. As I have stated before, we hope these two trials will be major catalysts for clinical adoption for both heart and lung throughout 2026 and beyond.”

TransMedics is the world’s leader in portable extracorporeal warm perfusion and assessment of donor organs for transplantation. Headquartered in Andover, Mass., the company was founded to address the unmet need for more and better organs for transplantation and has developed technologies to preserve organ quality, assess organ viability before transplant, and potentially increase the utilization of donor organs to treat end-stage heart, lung, and liver failure.