Organ Care System (OCS) Heart

2021: Announcement of a device for transporting the donor heart, which was previously considered unsuitable

On September 7, 2021, TransMedics launched a product called Organ Care System (OCS) Heart. It is an apparatus for transporting a donor heart, which was previously considered unsuitable.

The system is designed to be used with donor organs after brain death with indications to preserve donor hearts deemed unsuitable for purchase and transplantation in the initial evaluation. This restriction was imposed due to prolonged cold static cardioplegic preservation.

OCS is the first commercially available system that allows the beating donor heart to be maintained in a warm 34 ° C perfused oxygen state during a transplant from a donor hospital to a recipient hospital. This makes it possible to increase the time spent outside the body and minimize the harmful effects of cold ischemic storage.

Organ Care System (OCS) Heart

The authors group first used OCS to extract marginal donor hearts and observed that the use of OCS was associated with a marked improvement in short-term outcomes and an increase in the donor pool by the possibility of using organs previously considered unsuitable for transplantation. OCS can resuscitate marginal organs by reducing ischemic reperfusion injury and can contribute to enhanced function of marginal cardiac allografts.

According to TransMedics, this permission was obtained based on the results of the OCS Heart Expansion trial, the permanent access protocol and the OCS Heart Proceeding II trial.

Prior market clearance followed FDA approval and subsequent commercialization of the OCS Lung system, the company continues to seek FDA approval for the OCS Liver system, under which an FDA advisory panel gave a positive opinion in support of approval in July 2021.

We are very pleased to have reached this important milestone for heart transplantation in the US. This was the culmination of several years of collaboration with leading cardiac transplant experts and the FDA to ensure that our lifesaving OCS technology helps more heart transplant patients in the U.S., "TransMedics President and CEO Dr. Walid Hassanein said in a news release.

Dr. Walid Hassanein, also noted that they are honored that the OCS Heart System is now the only FDA-approved device designed to perfuse outside the living body and evaluate donor hearts and lungs as an alternative to the outdated cold storage method. The company TransMedics take this responsibility very seriously and look forward to the next stage of commercial activity, the start of the OCS Heart Perfusion Register (OHP) and the possible expansion of clinical indications.

Although overall heart transplant outcomes have improved since early 2000, primary graft dysfunction (PGD) remains one of the major limitations. The International Society for Heart and Lung Transplantation (ISHLT) defines PGD as a lesion of the left and/or right ventricle with echocardiographic and hemodynamic changes, the need for inotropic/vasopressor support and, as a rule, the use of artificial blood circulation devices. PGD, is the most common cause of early mortality after heart transplantation, accounting for up to 36% of deaths in the first 30 days. The prevalence of PGD ranges from 2.3 to 28% worldwide.^[1]

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