When 31-year-old Joshua Hosier began feeling out of breath frequently, he chalked it up at first to being out of shape and figured he should hit the gym.
But the symptoms worsened and led Hosier to see a doctor, who diagnosed him a year ago with a rare genetic disorder that causes emphysema. In January, he developed a lung infection that he believes could have killed him if doctors at the University of Maryland Medical Center hadn't used a device that's not yet approved in the United States to treat him.
"I just knew I didn't feel right, I felt worse than I had ever felt before," Hosier said. "If it wasn't for that machine I wouldn't be sitting here talking to you right now."
Hosier, who lives in Mechanicsville, St. Mary's County, has Alpha-1 antitrypsin deficiency. The disease is hereditary, said Dr. Si Pham, who treated Hosier as chief of cardiothoracic transplantation at the University of Maryland Medical Center.
"It's like emphysema early in life," Pham said of the disease. "The function of the lung is to help the lungs and the arteries remove carbon dioxide, and he was unable to get rid of carbon dioxide and he wasn't able to oxygenate efficiently."
Typically, doctors can hook patients who are having trouble getting enough oxygen to an oxygen machine, said Pham, also a professor of surgery at the University of Maryland School of Medicine. But there are fewer options for the second part of the lung's function — clearing carbon dioxide from the body.
Hosier said doctors considered a tracheotomy, but thought it might damage his airways in a way that would make it difficult for him to get a lung transplant later and likely would mean a stay in a rehab facility after treatment. Pneumonia was also a concern.
The hospital instead decided to treat Hosier with a machine called the Hemolung, which removes blood from a patient's body, clears of it carbon dioxide, then funnels oxygenated blood back into the body. The machine works similarly to the way dialysis machines perform as artificial kidneys.
Developed by Pittsburgh-based ALung Technologies Inc., the Hemolung is under review for approval by the U.S. Food and Drug Administration. ALung said the University of Maryland Medical Center is the second hospital in the country to use the Hemolung in an emergency.
After discussing the risks of using experimental technology with the university hospital's doctors, he and his family approved the treatment, Hosier said.
"At that point there was no other option for me other than dying, so I was willing to give it a shot," Hosier said. "Everybody was really confident that the machine was my best option."
Pham said the hospital secured a compassionate-use waiver to acquire a Hemolung machine and use it on Hosier. The waiver from the FDA allows use for some urgent situations even if the device is still awaiting approval.
"We're always concerned when we're using an unapproved device, but the device has been tested in Europe, so we know the device," Pham said. "Every time we do something to a patient, we have to balance the risks and the benefits."
After four days, Hosier's lungs were improved enough for him to be taken off the Hemolung, and now he is going through the process of getting a lung transplant.
Pham said he was glad to have the device available at the hospital for other patients who may face critical lung issues while awaiting a transplant.
"A number of patients die waiting, so having this device available to wait for a donor is quite helpful," he said.
Norman H. Edelman, a doctor and senior scientific adviser for the American Lung Association, said he thinks it could be helpful to test the Hemolung's effectiveness in "run-of-the-mill situations" such as when a patient with COPD — chronic obstructive pulmonary disease — comes to a hospital with a lung infection and needs treatment for a few days. The current standard treatment for such situations is mechanical ventilation, Edelman said.
"The question is, could we use this instead and would it be better for the patient?" Edelman said. "In my opinion, that's the next step."
Edelman, who had no knowledge of the internal FDA deliberations, said the agency must measure efficacy and safety when evaluating products.
"In general, the FDA is more cautious than the European regulatory agencies and it takes longer for things to get approved," he said.
Scott Morley, a spokesman for ALung, said the company is seeking an investigational-device exemption from the FDA that will allow them to conduct randomized controlled trials, a process they expect to take several years. Morley said the device has been cleared for sale in 34 countries, including Canada, Australia, Singapore and Chile.
For now, Hosier requires an oxygen tank for daily living and he said it makes playing with his 5-year-old son difficult, so he's hopeful he can get a lung transplant.
"I can't go outside and play catch with him," Hosier said. "As of right now the only thing my son will remember about me is that I was sick. With a lung transplant I can get some actual time with my son so he can actually get some memories of his father not hooked up to a machine."