TransMedics (Nasdaq:TMDX) announced today that it received FDA premarket approval (PMA) for its OCS Heart system.
FDA PMA allows Andover, Massachusetts-based TransMedics to expand the pool of eligible heart donors in the U.S. to organs from donors after circulatory death (DCD). The company had previously received PMA for the OCS Heart system for use with organs from donors after brain death (DBD) in September 2021.
OCS Heart now has approval with the extended clinical indication for ex vivo reanimation, functional monitoring and beating-heart preservation of donation-after-circulatory-death hearts. The new indication was based on results of the OCS DCD Heart Trial and associated Continued Access Protocol, TransMedics said in a news release.
According to the release, final and long-term results from that trial will be unveiled on Friday, April 29, at the International Society of Heart and Lung Transplantation (ISHLT) 2022 Annual Meeting in Boston.
“This first-of-its-kind DCD heart approval represents a transformative milestone for the U.S. heart transplant community as it stands to meaningfully expand the pool of eligible donor hearts while also enhancing our customer’s ability to utilize our OCS technology,” TransMedics President and CEO Dr. Waleed Hassanein said in the release. “The approval also marks the achievement of our final near-term regulatory milestone. We are now focused on leveraging our unique position to drive meaningful commercial traction and cement our global leadership position to transform transplant therapy for decades to come.”