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# TransMedics OCS Heart System Approved
- URL: https://www.fdaweb.com/transmedics-ocs-heart-system-approved/
- Published: 2021-09-07T12:00:00.000Z
- Updated: 2026-09-14T17:13:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150092

FDA has approved a TransMedics Group PMA for its OCS Heart System for use with organs from donors after brain death. The OCS Heart is a portable, warm perfusion, and monitoring system designed to keep a donor heart at a human-like, metabolically active state, the company says. By monitoring key parameters of the functioning heart, physicians may use their medical judgment to assess a potentially suitable heart’s condition and viability.  

The device is indicated for the preservation of donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation, TransMedics says. It allows surgeons to assess a donor heart’s viability in real time and minimizes the negative effects of cold storage, according to the company.