FDA Approves TransMedics’ OCS Heart System for Donor Hearts

The U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of TransMedics’ OCS Heart System for use with organs from donors after brain death (DBD).
 
The OCS Heart System is indicated for the preservation of DBD donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time). This indication is based on the results of the OCS Heart EXPAND Trial, the associated OCS Heart EXPAND Continued Access Protocol (CAP) and the OCS Heart PROCEED II Trial.
 
“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 CEO. “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.” 
 
“The approval of this revolutionary technology marks a critical step forward for heart transplantation,” said Dr. Jacob Schroder, surgical director of heart transplantation at Duke University Medical Center and the principal investigator for the OCS Heart EXPAND Trial. “The OCS Heart System allows surgeons to assess donor heart’s viability in real time and minimizes the negative effects of cold storage. This will increase utilization of donor hearts that are rarely used due to limitations of cold storage preservation. By expanding the donor pool of acceptable hearts, the OCS will enable us to better meet the growing demand for heart transplantation in the U.S. and save lives.”
 
The approval of the OCS Heart System follows FDA approval and subsequent commercialization of the OCS Lung System. TransMedics is also seeking FDA approval for its OCS Liver System, which received a favorable vote in support its approval by a panel of experts during an FDA Advisory Committee Meeting on July 14th.