TransMedics tells us that the PROCEED II heart transplant FDA pivotal trial results using its Organ Care System (OCS™) Heart platform have been presented at last week’s International Society for Heart and Lung Transplantation (ISHLT) 34th Annual Meeting and Scientific Sessions in San Diego, California.
Since the advent of organ transplantation, the cornerstone of organ preservation has been cold ischemic storage. Although this method is intended to reduce the extent of organ damage during transport, significant deterioration of the donated organ still occurs, and the longer the organ is kept on ice, the greater the damage. It is estimated that globally 70% to 80% of donor hearts cannot ultimately be used for transplantation, at least some of which is attriobuted to the limitations of cold storage.
TransMedics has developed the world’s only 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. Unlike simple cold storage, the OCS addresses the problem of cold ischemia injury by perfusing the organ with a blood based perfusate. In so doing it optimizes the condition of the organ by replenishing oxygen, nutrients, and hormones that would otherwise become depleted. And throughout the process, the OCS provides continuous monitoring and assessment of the organ until the point of transplantation
PROCEED II is a large international, multi-center, clinical trial designed to evaluate the ability of the OCS Heart Technology to preserve donor hearts compared with cold storage. It represents a pivotal study, results of which TransMedics will hope support its application for FDA clearance of the procedure. Indeed there is room for optimism, the trial having met its success criteria for both the primary effectiveness and safety endpoints by demonstrating that 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 Trial demonstrated that circulating lactate level of the OCS perfusion could be a useful parameter to evaluate donor hearts status ex-vivo.
The trial data has been submitted to the U.S. FDA as part of a pre-market 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 Dr. Waleed Hassanein, President and CEO of TransMedics, Inc.
Source: TransMedics , Inc., PR Newswire