To save the life of a loved one, would you risk an experimental treatment not yet approved by the FDA? Sallie Sacker did just that when her husband Jon lay on his death bed earlier this year. She opted for the Hemolung lung respiratory technology, and today her husband is the first individual in the United States to have received the revolutionary treatment, but most importantly, he is alive.
Earlier this year, Jon Sacker’s family gathered around his hospital bed, believing they would soon say goodbye to their beloved. Sacker has suffered from cystic fibrosis for his entire life, and after his first lung transplant failed, Sacker’s health took a turn for the worst. Although the Oklahoma man was hooked up to a ventilator to aid with breathing, the carbon dioxide levels in his bloodstream were increasing at a dangerous rate.
"I didn't see any other alternative other than withdrawing support from this young man," said Dr. Christian Bermudez, University of Pittsburgh Medical Center chief of cardiothoracic transplants, CBS Pittburgh reported. Respiratory dialysis was the last option. There was one big problem, though: There were no Hemolung machines in the entire United States.
Understanding the critical condition of Sacker, ALung Technologies' CEO Peter DeComo agreed to drive the device from Toronto to Pittsburgh. By the next day, Sacker was hooked up. Less than a month later, his health improved enough to receive the lung transplant. To Sacker, the device is nothing short of divine intervention. "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," explained the 33-year-old.
The Hemolung works as dialysis for the lungs, able to cleanse the patient’s blood of carbon dioxide. Developed by the company ALung Technologies, the Hemolung was designed for individuals suffering from acute hypercapnic respiratory failure, such as what occurs in patients with COPD. It is “a truly innovative medical device,” which offers patients “a much needed alternative treatment option,” DeComo explained in a recent press release. The device has the go-ahead for use in Europe and Canada but is still waiting the much stricter U.S. testing required for FDA approval. This will include “a randomized controlled trial to demonstrate safety and efficacy of the device in the U.S. population,” Scott Morley, a representative for ALung, told Medical Daily.
According to CBS, it could take between three and five years before the Hemolung is FDA approved. Unfortunately, Morley told Medical Daily that he believes Sacker’s case, although compelling, “is unlikely to result in lesser regulatory requirements with the FDA, due to these requirements being “mandated by federal legislation.” In order to get the device to Sacker in Pittsburgh, Sacker’s doctors had to apply for emergency compassionate use through the UPMC’s Institutional Review Board. “Once Jon was connected to the device, we had to provide frequent updates to the FDA relative to the performance of the device, whether we were having any adverse events, and the clinical condition of the patient,” DeComo said.