TransMedics (NSDQ:TMDX) announced today that it received FDA premarket approval for its OCS Heart system.
Andover, Massachusetts-based TransMedics designed its OCS Heart system for use with organs from donors after brain death with indication for preserving donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation, according to a news release.
The indication comes on the back of results from the OCS Heart Expand trial, the associated OCS Heart Expand continued access protocol and the OCS Heart Proceed II trial, the company said.
Premarket approval follows FDA approval for and the subsequent commercialization of the OCS Lung system as the company continues to seek FDA approval for the OCS Liver system, for which an FDA advisory panel issued a favorable vote supporting approval in July.
“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.,” TransMedics President and CEO Dr. Waleed Hassanein said in the news release. “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.”