Shots:
- TransMedics received US FDA conditional IDE approval to initiate its two-part Next‑Gen OCS ENHANCE Heart study evaluating prolonged heart perfusion (Part A) and superiority of OCS Heart in donation after brain death (DBD) cases vs static cold storage (Part B)
- The study will enroll >650 pts; Part B aims to expand OCS Heart indications to DBD hearts currently ineligible for OCS perfusion and preservation
- The company plans to start the ENHANCE Heart and DENOVO Lung Study in Q4’25, with both expected to drive adoption across heart and lung transplantation in 2026 and beyond
Ref: Businesswire | Image: TransMedics | Press Release
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