Overview of the FDA's Circulatory System Devices Panel virtual meeting on the TransMedics Organ Care System (OCS) Heart - portable extracorporeal heart perfusion and monitoring system.

Abstract

There are a limited number of donor hearts available for transplantation every year, and an even lower number of these hearts actually undergo transplantation. One of the barriers to utilizing donor hearts is the inferior outcomes associated with prolonged ischemic times. There have been increasing attempts to develop alternative techniques for prolonged storage to raise the number of heart transplants while maintaining acceptable outcomes. One such new technology utilizes continuous ex vivo perfusion of the donor heart with oxygenated blood and allows for prolonged storage and preservation times. The TransMedics Organ Care System (OCS) Heart (TransMedics; Andover, MA) claims to optimize the condition of the donor organs by preserving them in a warm, functioning environment. On April 6, 2021, the United States Food and Drug Administration convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to provide guidance on the TransMedics OCS Heart System's application for premarket approval. This application was subsequently approved on September 7, 2021. We provide an overview of the meeting, including the results of the clinical trials that were presented.