MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
Transplant medicine advances
from a cooler of ice to LifePort
By LYNN YOFFEE
Medical Device Daily Staff Writer
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 FDAapproved
in 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.
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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 posttransplant
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 latestage
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
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