TransMedics Announce Final Results of PROCEED II Heart FDA Pivotal Trial at ISHLT


April 23, 2014

April 23, 2014 — The PROCEED II heart transplant U.S. Food and Drug Administration (FDA) pivotal trial results using the Organ Care System (OCS) Heart platform were announced at the International Society for Heart and Lung Transplantation (ISHLT) 34th annual meeting and scientific sessions in San Diego.

The OCS Heart PROCEED II FDA pivotal trial met its success criteria for both the primary effectiveness and safety endpoints by demonstrating the OCS is as safe and effective as the current standard of care (SOC) in preserving standard donor hearts for transplantation. These results were achieved despite the OCS arm having significantly longer total cross clamp time as compared to SOC. In addition, the data from PROCEED II demonstrated that circulating lactate levels of the OCS perfusion could be a useful parameter to evaluate donor hearts status ex vivo.

The trial data has been submitted to the FDA as part of a premarket notification and is currently under review by the agency.

"The successful completion of our OCS Heart PROCEED II trial and the filing of our FDA marketing application is an important milestone for TransMedics. This large international trial could be the defining work towards establishing ex vivo heart perfusion as a viable clinical option for donor heart preservation for transplantation to overcome the challenges of cold ischemic storage," said Waleed Hassanein, M.D., president and CEO of TransMedics Inc.

Since the advent of organ transplantation, the cornerstone of organ preservation has been cold ischemic storage (essentially placing organs on ice). Although this method is intended to reduce the extent of organ damage during transport, significant deterioration of the donated organ still occurs. The longer the organ is kept on ice, the greater the damage. Moreover, the cold storage technique does not enable any optimization or monitoring while the organ is being transported from donor to recipient. Partly because of the limitations of cold storage, it is estimated that globally, 70 to 80 percent of donor hearts cannot ultimately be used for transplantation.

TransMedics has developed a portable medical device capable of overcoming the limitations of cold storage for organ transplantation. The OCS technology was designed to provide a comprehensive solution to all three key limitations of the cold storage technique. The OCS minimizes cold ischemia injury by perfusing the organ with a blood-based perfusate; optimizes the condition of the organ by replenishing oxygen, nutrients and hormones that would otherwise become depleted; and provides continuous monitoring and assessment of the organ until the point of transplantation.

These unique capabilities of the OCS technology have the potential to improve patient survival, reduce post-transplant complications, increase utilization of current donor organs and improve cost effectiveness of the transplant procedure

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