TransMedics Group, a Massachusetts-based healthcare technology company focused on organ transplantation, announced that its new solution for preserving hearts from donors after brain death has gained FDA approval.
The company’s OCS Heart System preserves hearts from donors after brain death that can’t be procured or transplanted right away due to the limited availability of cold storage.
The FDA’s decision to approve this new solution is based on three different clinical trials, including the OCS Heart EXPAND Trial.
“We are thrilled to achieve this important milestone for heart transplantation in the United States,” Waleed Hassanein, MD, president and CEO of TransMedics, said in a prepared statement. “This was the culmination of several years of collaboration with leading heart transplant experts and FDA to bring our lifesaving OCS technology to help more heart transplant patients in the United States.”
“The OCS Heart System allows surgeons to assess donor heart's viability in real time and minimizes the negative effects of cold storage,” added Jacob Schroder, MD, surgical director of heart transplantation at Duke University Medical Center and principal investigator of the OCS Heart EXPAND Trial. “This will increase utilization of donor hearts that are rarely used due to limitations of cold storage preservation.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.