TransMedics Group, Inc., a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its Investigational Device Exemption (IDE), allowing the company to proceed with the initiation of its Next-Generation OCS ENHANCE Heart trial.
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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 DBD hearts that are not currently eligible for OCS perfusion and preservation. The trial’s total sample size, across both Part A and Part B, is expected to exceed 650 patients. TransMedics believes this would constitute the largest heart preservation for transplant trial ever, worldwide.
“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 Waleed Hassanein, MD, President and Chief Executive Officer. “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.”
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Source- PR Newswire
