Jon Sacker, 33, was born with cystic fibrosis. In late February, he was in desperate need of a double-lung transplant — his second — but was too weak for the operation.
Doctors knew he needed to regain strength in his lungs almost immediately. His life was at stake.
"I thought I had brought my husband here to die," Sacker’s wife, Sallie, said of bringing him to University of Pittsburgh Medical Center (UPMC) from their hometown of Moore, Oklahoma.
Sallie Sacker told the Associated Press that they almost turned off her husband's ventilator, "because we were putting him through suffering."
And then the phone rang.
UPMC clinicians had an idea: Use the Hemolung Respiratory Assist System (RAS), a Pittsburgh-made device that could filter out the harmful carbon dioxide and provide healthy oxygen to Sacker's blood, sort of like dialysis for the lungs, the Associated Press described.
The only problem: While the Hemolung is American-made, it's not currently approved for use by the FDA. It was, however, approved for use in Canada and Europe. Once UPMC doctors managed to get permission to use the Hemolung RAS in this case of emergency from the FDA and local hospital safety officials, they had to actually track one down.
The closest available Hemolung was in Toronto. Doctors feared Sacker wouldn't live long enough to have one shipped to them.
So Peter M. DeComo, CEO of ALung Technologies (the company that made the Hemolung) drove through the night with Alethea Wieland, ALung's director of clinical affairs, to meet Murray Beaton of Novus Medical, Inc, in Oakville, who was waiting for him with a Hemolung at the Canadian border.
DeComo then managed to bring the unapproved device back over the border by explaining to the guard that, as CEO of ALung, he was simply retrieving his own property.
The Hemolung was at the hospital by 8 a.m. the next morning. That afternoon, Sacker became the first person in the U.S. to be implanted with the Hemolung RAS.
"He immediately started to improve," DeComo said.
Twenty days later, Sacker received his second lung transplant. He is recovering well.
"That machine is a lifesaver," Sacker said from the University of Pittsburgh Medical Center.
"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," he added.
Sacker's family praised DeComo and doctors for their invention. The Toronto Star reported that members of Sacker's family showed up at ALung to personally thank staff for their life-saving device.
"God used all of these people and circumstances to save Jon David," Sacker's family wrote on their blog. "This...was nothing short of a succession of miracles and deliverance. Because of His great intervention, that hemolung kept Jon David alive. To God be the glory forever."