TransMedics Group has won a PMA for a device designed for the preservation of hearts from donors after brain death (DBD).
The Andover, MA-based company said its OCS Heart System is for 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.
"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 company is working on gaining 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.
The firm has already won FDA approval and commercialized its OCS Lung system.