$5,000 device by Novalung device

Owen Stark in July when he used an artificial lung. He was the youngest patient on the machine. (St. Louis Children's Hospital)

When Owen Stark came to St. Louis Children's Hospital in June with severe lung disease, he had just a few days to live and even fewer options for treatment.
Owen, 2, had severe pulmonary hypertension, meaning the blood vessels in his lungs were so constricted they could barely carry blood. He had to go on life support to keep his heart and lungs functioning. Medications for the disease can take weeks or months to improve a patient's condition. Waiting for a suitable lung transplant can add another two to six months.

"Transplant or medication, both options take time, and he didn't have time," said Dr. Mark Grady, Owen's cardiologist.

A surgeon on the team had heard of an artificial lung used in Europe and Canada, but not approved for long-term use in the United States. The hospital appealed for a compassionate use exemption, which was granted in about three days by the Food and Drug Administration.

Owen's parents, of Eldon, Mo., were shocked by the rapid deterioration of the boy who seemed energetic and healthy just hours before he was hospitalized. They agreed to the experimental treatment.

"We were really nervous about it, but at that point he had no other options to live." Justin Stark said.

Surgeons implanted Owen with the Novalung device, a small box with two tubes on either side that are attached to the heart. Blood goes through one tube into the box, where oxygen is added and carbon dioxide is removed, and then the blood returns to the heart through the other tube.

Hospital officials were eager to promote the story to the public, as the first time the $5,000 device had been used on a patient in the U.S.

But Owen's doctors resisted public and media attention until they knew Owen wasn't going to die.

After about three weeks on the device, Owen was feeling pretty vigorous, and kicked one of the tubes loose. Somehow a blood clot dislodged and the little boy suffered a stroke.

The doctors decided to remove the device, and Owen has been breathing on his own ever since.

Owen lost mobility on his right side and his speech was affected by the stroke. He's in therapy and still takes three drugs for lung function.

Doctors say they're in a wait-and-see mode. Owen's lungs could stop functioning again and he might still need a lung transplant. Or he could leave the hospital and go home in a month.

"His prognosis is guarded," Grady said. "He's clearly shown a good response to the meds. Only time will tell whether he'll stabilize."