The days of lugging a life-giving organ around in an Igloo cooler full of ice cubs may soon be over.
“We believe the ice age is over,” said Waleed Hassanein, founder and president of TransMedics, during a tour of his Minuteman Road company on Friday of last week.
TransMedics, which has been in Andover since 2004, is a pioneer in a new field of medicine called ex-vivo warm blood perfusion for transplantation.
Called the Organ Care System, the device, more commonly referred to as the “heart in a box,” is the only technology known to be capable of maintaining a functioning human organ and keeping it alive, beating, breathing and doing everything else a human organ would do inside the body.
“Before TransMedics, there was no concept of this machine perfusion to keep organs alive outside of a human body,” Hassanein said. “We’re very proud of it. We’re very humbled by the fact that we’ve pioneered it and want to continue to lead it.”
The system has been in use for many years in transplant centers in Europe and Australia. TransMedics has been working for the last eight years to gain approval for its wide use in the U.S.
Currently, the average life span for an organ outside of a body for transplant is three to four hours. With TransMedics’ technology, there is no time limit.
The company has successfully transplanted a heart up to 12 hours after it’s been removed, a lung after 18 hours and a liver up to 24 hours later.
He added, “As long as the heart is beating and perfused in our system, there really is no time limitation.”
The CEO was speaking to a group of local, state and federal leaders who toured the facility last Friday as part of National Manufacturing Day, which was a celebration on domestic manufacturing.
U.S. Rep. Niki Tsongas, newly appointed Andover Town Manager Andrew Flanagan and state Sen. Barbara L’Italien, D-Andover, among others, were on hand to learn about the device and the company’s work.
Teams overseas are now using the device to transplant hearts from deceased patients, which is creating a whole new population of donors, Hassanein said.
“We’ve taken 17 hearts from patients whose hearts stopped beating for 30 minutes, we’ve revived the heart on the Organ Cares System, monitored its function for five to six hours and there are (now) 17 people alive and well in the U.K. and Australia,” he said.
The company is close to its finish line in bringing the technology to Americans. It is scheduled to present its system to the FDA on Nov. 18.
Hassanein and his team have prioritized the approval process to target its use for hearts first, then lungs, followed by kidneys, the pancreas and small bowl.
If all goes well with the FDA next month, the company hopes the heart system will be active in the U.S. in the first quarter of 2016, followed by its use with lungs in the second quarter.
“We want this technology in the U.S.,” he said.