TransMedics Group, Inc. (NASDAQ:TMDX) received premarket approval (PMA) from U.S. Food and Drug Administration (FDA) for its OCS™ Heart System in favour of use with organs from donors after circulatory death (DCD).
This approval is based on the results of the OCS™ DCD Heart Trial and the associated Continued Access Protocol (CAP) and stands to significantly expand the pool of eligible donor hearts in the United States.
FDA granted PMA to the OCS™ Heart System for use with organs from donors after brain death (DBD) in September 2021.
Waleed Hassanein, MD, President and Chief Executive Officer, commented, “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”.
The company is scheduled to present final and long-term results from the trial at the ongoing International Society of Heart and Lung Transplantation (ISHLT) 2022 Annual Meeting in Boston, MA, on Friday, April 29, 2022.
TransMedics Group is currently trading high 4 percent at $21.36.
