TransMedics Reports Positive Data From OCS DCD Heart Trial

TransMedics Group Inc TMDX has announced topline results from its OCS donors after circulatory death (DCD) Heart Trial.
Related: TransMedics' OCS Heart System Scores FDA Approval.
The OCS DCD Heart Trial was designed to compare post-transplant clinical outcomes between hearts transplanted from DCD donors preserved on the OCS Heart System and hearts transplanted from donors after brain death (DBD) kept using the current standard cold storage in the U.S.
The OCS DCD Heart trial achieved its primary clinical objectives by meeting the primary effectiveness endpoint of 6 months patient survival post-transplant, 95% for the OCS DCD arm vs. 89% for the DBD Control arm.
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 ongoing, and the final results will be presented at the upcoming Scientific Meeting of the International Society for Heart and Lung Transplantation in April 2022.
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