ALung CEO Peter DeComo sped north toward Canada on a deserted highway in the middle of the night, racing to save the life of a man he had never met. To do it, he would have to get past the border guard with a medical device that's not legal in the United States.
The dying man's name was Jon Sacker, and he had cystic fibrosis. He received a double lung transplant in 2012, but now an infection had damaged his new lungs, and his body was rejecting them. A second transplant had finally been scheduled at the University of Pittsburgh Medical Center, which was no small feat in itself. Fewer than 2,000 lung transplants were performed in 2013, and only 80 of those on patients who had already received transplanted lungs. As the surgery approached, however, Sacker's condition deteriorated. A ventilator provided the oxygen he needed, but lethal levels of carbon dioxide were building up in his blood.
If there were another organ, the solution would have been relatively simple. Patients awaiting a kidney transplant can undergo dialysis, and those awaiting a new heart can have a pump implanted. The only machine available to temporarily replace the lungs is called extracorporeal membrane oxygenation, or ECMO. The technology had been around for decades, and few hospitals even have access to the machine. It is extremely difficult to use properly, even for trained medical technicians.
"The lung is an amazing organ for gas exchange. It's not so easy to develop a mechanical device that can essentially replace the function of a lung," says bioengineer William Federspiel, who helped design the Hemolung.
Fortunately for Sacker, Dr. Christian Bermudez, the chief of cardiothoracic transplants at UPMC, remembered the Hemolung. Hemolung was invented by a team of Pittsburgh engineers as a way to replace the function of working lungs. The device had already been approved in Europe and Canada, but the more stringent testing the Federal Drug Administration requires has not yet been completed.
Bermudez contacted ALung, the company responsible for Hemolung, as well as the FDA, trying to convince them to allow the device to be used on Sacker. Both parties approved, but it would take a few days for ALung to have a device shipped to Pittsburgh. Sacker didn't have that long.
DeComo heard about the problem around 11 p.m. and immediately set out to find the nearest Hemolung device. As it turned out, that was in Oakville, Ontario, nearl 300 miles away. Murray Beaton, who works for the company in charge of Hemolung distribution in Oakville, agreed to drive the device south and meet DeComo just inside the Canadian border. The two met at an empty intersection, and Beaton handed off the Hemolung. However, the mission wasn't over yet.
DeComo was stopped trying to re-enter the U.S. The border guard could not allow a medical device unapproved by the FDA to enter the country. DeComo argued that technically he wasn't importing anything. The Hemolung was made by ALung, and as the CEO, he was simple retrieving his property. After calling his superiors, the guard ageed, and DeComo went speeding back toward Pittsburgh.
He arrived with the device at around 8 a.m., and got to work assembling the device and connecting it to Sacker. The Hemolung is hooked up to a patient's veins and blood is passed through it. Using small tubes filled with oxygen, the Hemolung removes carbon dioxide from the blood and replaces it with pure oxygen. Sacker remained connected to the device for some time, and 20 days later he successfully underwent his second lung transplant.
"That machine is a lifesaver," says Sacker. "You get a call at the last second about a device that has never been used here in the United States -- that's a miracle."
