TransMedics® Announced Final Results of The PROCEED II Heart FDA Pivotal Trial at ISHLT
ANDOVER, Mass., April 14, 2014 /PRNewswire/ — The PROCEED II heart transplant Food and Drug Administration (FDA) pivotal trial results using the Organ Care System (OCS(TM)) -Heart platform were announced on Saturday, April 12, 2014 at the International Society for Heart and Lung Transplantation (ISHLT) 34(th) Annual Meeting and Scientific Sessions in San Diego, Calif.
The OCS Heart PROCEED II FDA pivotal trial 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.
What is the TransMedics Organ Care System (OCS)?
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% of donor hearts cannot ultimately be used for transplantation.
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. 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; -- 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 -- Improve cost-effectiveness of the transplant procedure
About PROCEED II Heart Trial
PROCEED II Trial 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. For more information, please visit www.clinicaltrials.gov.
About TransMedics, Inc.
TransMedics is a privately held medical technology company dedicated to extending the life saving benefits of organ transplantation to patients suffering from end-stage organ failure. Headquartered in Andover, Massachusetts, the company was founded in 1998 to address the unmet need for more and better organs for transplantation. For more information, please visit www.TransMedics.com.
SOURCE TransMedics, Inc.