Owen Stark has pulmonary hypertension -- high blood pressure in his lungs that stresses his heart. He was in heart failure this June when he arrived at Children's.
"The disease this little boy has, if the medications fail, transplant is
the next step," Dr. Mark Grady, a pediatric cardiologist at Children's
who has worked with Owen, told the Daily RFT.
Owen was already in such dire condition when he arrived that a transplant was critical, but organs weren't available.
So the transplant team at Children's realized that using the Novalung
sLA, which isn't approved for use as an artificial lung, but rather as a
temporary solution during surgery, could be his only hope.
The Novalung sLA had, until Owen, only been used in adults and only for
six hours at a time during surgery. But Owen's doctors, realizing the
situation was critical, applied for and received "compassionate
approval" from the Food and Drug Administration to use the device in a
new way -- on a pediatric patient, and for an extended period of time.
He stayed on the device for 23 days, and did so well that his lungs are now functioning on their own.
"Currently he's doing okay," says Dr. Grady. His disease isn't curable, so the outlook remains guarded.
But the compassionate approval from the FDA may set the stage for further use of the device as an artificial lung in kids in crisis.
"If we came across a similar situation, we could use it again," Grady
says. "It happens all the time in pediatrics. We'll probably in some way
alert the medical community."
A 2-year-old boy from Eldon, Mo. is alive today thanks to a novel use of an artificial lung at St. Louis Children's Hospital. And his treatment may pave the way for other kids to make use of artificial lungs as well. He's the youngest person ever to use the German-made device, the Novalung sLA Membrane Lung.