TransMedics Group (NASDAQ:TMDX) reported positive topline results from its OCS donors after circulatory death (DCD) heart trial.
The OCS DCD heart trial was designed as the first and only randomized trial to compare post-transplant clinical outcomes between hearts transplanted from DCD donors that were resuscitated and assessed on the OCS Heart System and hearts transplanted from donors after brain death (DBD) that were preserved using the current standard of cold storage in the U.S.
The OCS DCD heart trial achieved its primary effectiveness endpoint of six months patient survival post-transplant, which was 95% for the OCS DCD arm, compared with 89% for the DBD control arm.
Even when the outcomes were adjusted for all risk factors between the two groups, the results were 94% for OCS and 90% for control. Of 101 DCD donor hearts that were perfused and assessed on OCS Heart technology, 90 were successfully transplanted resulting in a utilization rate of 89%. Long-term follow-up is continuing.
The OCS Heart System was approved by the FDA for its DBD heart indication in September 2021. These OCS DCD Heart trial results will be submitted shortly to FDA in a PMA supplement to support the approval for the OCS DCD heart indication.
“The more widespread use of DCD hearts for transplantation is the biggest thing to happen since the beginning of heart transplantation,” Dr. Jacob Schroder, surgical director of heart transplantation at Duke University Medical Center and the principal investigator for the OCS DCD heart trial, said in a statement.
Dr. David D’Alessandro, surgical director of heart transplantation at Massachusetts General Hospital and the co-principal investigator for the OCS DCD heart trial agreed. “We now have a unique technology that will allow us to offer this life saving therapy to more patients than ever before.”
Waleed Hassanein, M.D., president and CEO of TransMedics, said the clinical results are “transformative” to the field of heart transplantation. “The trial met and exceeded the very high bar of comparing transplant clinical outcomes of OCS DCD heart to standard criteria DBD heart in the U.S., which are known to be the best in the world.”
