TransMedics (Nasdaq:TMDX) announced today that the FDA says it can proceed with the initiation of a trial for its OCS Heart System.
The FDA granted conditional approval of the company’s investigational device exemption (IDE). It allows the Andover, Massachusetts-based company to proceed with the initiation of its next-generation OCS ENHANCE trial.
ENHANCE, a two-part clinical trial, evaluates the system’s support for prolonged heart perfusion. It then aims to demonstrate the superiority of the OCS Heart perfusion in donation after brain death (DBD) cases. The study compares this to DBD cases using static cold storage methods.
TransMedics says the second part aims to support the potential expansion of its clinical indications to include DBD hearts not currently eligible for OCS perfusion and preservation. The company expects the trial, across both parts, to exceed 650 patients. It says this would mark the world’s largest heart preservation for transplant trial ever.
“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,” said Dr. Waleed Hassanein, president and CEO. “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.”
