CHICAGO, Dec. 31 A landmark study published today in the New England Journal of Medicine (NEJM) demonstrates that use of a specially-designed machine to store kidneys for transplantation offers significant benefits in kidney survival and function when compared to those stored in a traditional "ice box", or cold storage. Unlike the icebox, the LifePort(R) Kidney Transporter monitors the temperature and vascular performance of the organ in real time, while preserving it by pumping the kidney continuously with a cold solution, even while the organ is being transported to its intended recipient.
"This important study confirms the critical role that transportable machine perfusion can play in improving kidney transplant outcomes," said David Kravitz, Chief Executive Officer of Organ Recovery Systems, the manufacturer of LifePort. "It also demonstrates that LifePort should have a central place in all transplantation programs, to help ensure the best possible patient outcomes."
The international trial enrolled kidney pairs from 336 consecutive deceased donors in Europe and randomly assigned one kidney to machine perfusion and the other to static storage. Results showed that the odds of a delay in kidney function post transplant were reduced by almost half when machine perfusion was used compared with static cold storage. Delay in kidney function, or DGF, is a factor that is known to adversely affect the long-term outcome of kidney transplantation. The study also showed that the LifePort kidneys were 48 percent less likely to fail within the first year post-transplant compared to those kidneys stored in the traditional box of ice prior to transplantation. This is the first randomized, prospective study to directly compare the two methods of storing and transporting organs for transplantation.
"For the first time in the United States, the number of those waiting for a life-saving transplant has passed 100,000," said Joseph Vassalotti, MD, Chief Medical Officer of the National Kidney Foundation. "Any new method like the one demonstrated in this study, that will help maximize the available organs and potentially reduce the need for re-transplantation, is vitally important for patients and the professionals who care for them."
More than 1.5 million people worldwide suffer from end stage renal disease, for which a kidney transplant is the preferred treatment option. With a continuing global shortage of organs for transplantation, it is important to find ways of increasing not just the number of kidneys available but also the quality of organs for transplantation to improve the long-term outcome for recipients. By improving the quantity and quality of organs for transplant, both improvements in clinical outcomes and cost savings to health systems are likely to occur.
The LifePort provides a sealed, sterile, protected environment where a physiologic solution is gently pumped through the kidney at cold temperatures to minimize damage while the organ is outside the body. The LifePort is lightweight and portable allowing organs to be perfused and evaluated from the time of recovery until transplant. It can travel unaccompanied by land or air, safely transporting the kidneys across town or between states.
About the Machine Preservation Trial
The Machine Preservation Trial was an investigator-driven study, run by an independent Scientific Steering Committee across The Netherlands, Belgium and Germany, with Eurotransplant (an international organ exchange organization) collaborating as study coordinators. The Machine Preservation trial was sponsored by Organ Recovery Systems of Chicago, USA, manufacturers of the LifePort Kidney Transporter.
About Organ Recovery Systems
Organ Recovery Systems is a division of Lifeline Scientific Inc., a Chicago-based global medical technology company with European headquarters in Brussels. Organ Recovery Systems develops advanced perfusion techniques to improve the quality and quantity of organs, tissues and cells for transplantation. Working with a team of leading transplant professionals, Organ Recovery Systems develops medical devices, chemical solutions and techniques to improve the process by which cells, tissues and organs are treated -- from the time of donation to the time of transplantation.
Organ Recovery Systems initial product is the LifePort Kidney Transporter. During its pilot introduction phase, 270 LifePorts have perfused more than 12,000 kidneys in transplant programs worldwide. Medical devices for ex vivo preservation of the heart, lung, pancreas and liver are in pre-clinical development.
SOURCE Organ Recovery Systems