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FDA Greenlights Next-Gen Heart Transplant Trial
10 Feb
Summary
- FDA approved the OCS ENHANCE Heart trial for next-gen organ preservation.
- Trial Part B compares new perfusion to cold storage in heart transplants.
- Over 650 patients will be enrolled across both trial parts.
The US Food and Drug Administration (FDA) has fully approved TransMedics Group's OCS ENHANCE Heart trial. This significant development focuses on evaluating next-generation portable extracorporeal warm perfusion systems for donor organs.
The trial is divided into two parts. Part A will assess prolonged heart perfusion using the OCS Heart system. Part B is designed to compare this advanced perfusion method with conventional static cold storage in donation after brain death cases. The goal is to broaden the use of OCS Heart for standard criteria DBD hearts.
This comprehensive study anticipates enrolling over 650 patients. TransMedics, headquartered in Andover, Massachusetts, specializes in technologies that maintain organ quality pre-transplantation, aiming to boost the utilization of lungs, livers, and hearts for transplantation. The company expects this trial to be a major catalyst for heart and lung adoption.
President and CEO Waleed Hassanein expressed enthusiasm, stating the trial's aim is to demonstrate the OCS Heart platform's ability to enhance cardiac function and prove its superiority over cold storage. This randomized, controlled, and blinded trial is poised to provide robust clinical evidence for improved heart transplantation outcomes.
