The US Food and Drug Administration (FDA) has conditionally approved TransMedics Group’s investigational device exemption (IDE) to commence the next-generation OCS ENHANCE Heart study.
Part A of the trial will focus on supporting prolonged heart perfusion leveraging the OCS Heart System.
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OCS Heart comprises a portable, warm perfusion system, which is said to maintain a donor heart in a metabolically active state, allowing physicians to monitor and assess the heart’s condition and viability.
Part B aims to demonstrate the OCS Heart perfusion’s superiority in donation after brain death (DBD) cases over traditional static cold storage methods.
This part is aimed at supporting the potential expansion of the system use for DBD hearts, which are currently ineligible for OCS perfusion and preservation.
The anticipated sample size for both parts of the trial is set to exceed 650 subjects, which the company believes would make the largest heart preservation for transplant trial ever worldwide.
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By GlobalDataTransMedics Group CEO and president Waleed Hassanein said: “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 addressing the major clinical needs of the cardiothoracic transplant community.
“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.”
In 2023, the company completed the acquisition of a premier US charter flight operator, Summit Aviation. This move has established TransMedics Aviation as the first dedicated national air logistics provider exclusively for organ transplantation in the US.
