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.
The FDA approval is based on the data from the OCS Heart EXPAND trial, as well as the associated OCS Heart EXPAND continued access protocol (CAP) and the OCS Heart PROCEED II trial.
TransMedics Group president and CEO Waleed Hassanein said: “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 US.
“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 OCS Heart System will enable surgeons to evaluate donor heart’s viability in real time and reduce the negative effects of cold storage.
It is believed to support in better meeting the increasing demand for heart transplantation in the US by expanding the donor pool of acceptable hearts.
The approval of the OCS Heart System is said to follow FDA approval and subsequent commercialisation of the OCS Lung System.
In addition, the company is seeking FDA approval for its OCS Liver System, which secured a positive vote in support its approval by a panel of experts during a FDA advisory committee meeting in July this year.
