Medical Device Daily

Just as the new year begins, researchers have pushed open a massive door in the field of organ transplantation medicine that will offer expanded opportunities for more transplants with far better outcomes.

A machine developed by Organ Recovery Systems (ORS; Chicago) that stores kidneys for transplant has been proven in a landmark study indicating an ability to vastly improve the survival and function of organs. This compares to the most common, and rudimentary, transport method currently available: a bag of ice in a cooler – or essentially the kind of treatment normally offered the standard six-pack of beer.

The ORS technology has promising applications for liver, heart, pancreas and lung transplants too, according to the company.

"Organ transplantation medicine has finally reached the 21st century," David Kravitz, CEO of ORS told Medical Device Daily.

So notable is this technology advance – an egg-shaped, 20-pound device that's about the size of a carry-on suitcase – that it has been added to the permanent collection of New York's Museum of Modern Art.

"We made it iconic-looking to make a statement in terms of the physicality of it – to set it apart from the box of ice," Kravitz said. "But it's built to be rugged because we knew it had to go as robustly anywhere that a box of ice would go, including being unattended in the cargo hold of an airplane."

The company's LifePort Kidney Transporter was FDA-approved in 2003 (MDD, Aug. 6, 2003), but when ORS first received that approval, it didn't have the financial guns to run a pivotal trial.

Thus, the system has been used only on a pilot, introductory basis, to date.

But a study published in the current issue of the New England Journal of Medicine now proves that use of the LifePort, which preserves a kidney by continuously pumping a temperature-controlled nutrient solution through the organ and monitors performance in real time, offers significant benefits in organ survival and function compared to those that are moved from donor to patient in an iced cooler.

The international trial reported in the NEJM enrolled kidney pairs from 336 deceased donors in Europe and randomly assigned one kidney to machine perfusion and the other to static (ice) 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.

The study is considered a landmark because it's the first randomized, prospective study to compare the two methods of storing and transporting organs.

"We needed to set the story straight on the differences between our machine and bags of ice," Kravitz said.

Comparing the progress and development of the system to making a "movie," he said it was shot "out of sequence, but it was really an artifact of funding. In this study, the investigators were trying to answer an age-old question in renal transplantation: does a machine improve the outcome of a transplant vs. a box of ice?"

Delay in function is a relatively common complication that affects the long-term outcome of kidney transplants. The study also proved that the LifePort kidneys were 48% less likely to fail within the first year, post-transplant, compared to those kidneys stored in the traditional box of ice prior to transplantation.

"Delayed graft function is a term that defines a post-transplant episode where the kidney doesn't immediately function and the patient must be dialyzed," Kravitz said. "It's painful, causes complications and involves longer hospital stays."

In the early days of transplantation medicine, the ideal donor was the young motorcycle accident victim, with a closed-head injury, whose organs were all healthy and intact, Kravitz explained. Older donors and those who weren't as healthy weren't even considered because of the possibility that their organs wouldn't survive or wouldn't perform well.

"Over time, the donor community has grown, demand has grown dramatically, and the average donor has a broader definition of secondary medical conditions and age that can be considered," Kravitz said.

More than 1.5 million people worldwide suffer from end-stage renal disease, for which a kidney transplant is the best treatment option. The National Kidney Foundation (NKF; New York) reports that the number of those waiting for a transplant has passed 100,000.

"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," said Joseph Vassalotti, MD, chief medical officer of NKF.

Beyond kidneys, LifePort is considered to be a platform technology.

"It was designed to be extended to other organ types without changing a whole lot," Kravitz said. "We have late-stage prototypes that have been evaluated in large mammal models. We're considering in 2009 how to move them forward."

Although an exact commercial pricing model hasn't yet been established, he estimated the cost of the base hardware at $15,000 to $20,000 per unit. Machine life expectancy is unknown, although the units that have been in pilot use, now for four years, show no signs of wearing out.

Training on how to use the LifePort is relatively easy: "An average-trained medical technician can learn how to use this in a few hours," Kravitz said.

ORS sub-contracts the manufacturing and anticipates full commercial launch in 2009, with a strong thrust first in the U.S. and Canada followed shortly after by launches in Europe (where CE mark was already obtained) and Brazil.