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FDA approves TransMedics’ OCS Heart system

TransMedics Group has secured approval from the US Food and Drug Administration (FDA) for its OCS Heart System that is developed for use with organs collected from donors after brain death (DBD).

  • FDA approves TransMedics OCS Heart system

TransMedics Group has secured approval from the US Food and Drug Administration (FDA) for its OCS Heart System that is developed for use with organs collected from donors after brain death (DBD).

The OCS Heart System is designed to preserve DBD donor hearts deemed unsuitable for procurement and transplantation at initial assessment due to limitations of prolonged cold static cardioplegic preservation.

"We are thrilled to achieve this important milestone for heart transplantation in the United States. This was the culmination of several years of collaboration with leading heart transplant experts and FDA to bring our lifesaving OCS technology to help more heart transplant patients in the U.S.," said Waleed Hassanein, MD, President and Chief Executive Officer. "We are honored and humbled that the OCS Heart System is now the only FDA approved device indicated for ex-vivo perfusion and assessment of both donor hearts and lungs as an alternative to the antiquated cold storage preservation. We take this responsibility very seriously, and we are looking forward to the next phase of commercial activities, the initiation of the OCS Heart Perfusion (OHP) Registry, and potentially expanding our clinical indications in the future." 
 

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