The FDA’s Circulatory Systems Device Advisory Panel issued a favorable vote in support of approval of TransMedics Group’s (NASDAQ:TMDX) OCS Heart System to the FDA’s Office of Health Technology 2 (Cardiovascular Devices).
The panel voted 12-to-five, with one abstaining, that the benefits of the OCS Heart System outweigh its risks; 10-to-six, with two abstaining, that there is reasonable assurance that the OCS Heart System is effective; and nine-to-seven, with two abstaining, that there is reasonable assurance of the OCS Heart System’s safety.
The FDA advisory panel reviewed clinical evidence from TransMedics’ OCS Heart EXPAND trial, the associated Continued Access Protocol results, as well as the OCS Heart PROCEED II trial.
TransMedics is a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure.
“This is a critical milestone for the OCS Heart technology on the path to a potential FDA approval, which I am confident would benefit patients in need of heart transplantation in the U.S.,” Waleed Hassanein, M.D., president and CEO of TransMedics, said in a statement.
“We are now laser focused and looking forward to our next important business milestones planned for 2021: the scheduling the OCS Liver FDA Advisory Panel Meeting; the final readout of the OCS Heart DCD trial; and the filing of the DCD Heart PMA supplement to eventually expand our OCS Heart indication into DCD heart transplantation in the U.S.,” he added.
Dr. Maryjane Farr, medical director of the transplant program at Columbia University Irving Medical Center, said the potential opportunity to expand the donor pool for heart transplant candidates using the TransMedics device in select patients would be a major advance in the field of heart transplantation.