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.
Since the early days 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 because it:
- 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
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.