Dr. Charles Fraser, Chief Pediatric Surgery at Texas Children's Hospital, said, "We view this as a giant step forward for children who have … historically not had the option of such a device for supporting failing circulation."
The Berlin heart has not yet earned FDA approval. But over the next three years, Texas Children's, along with 10 other hospitals, will collect data on the device and report back to the FDA.
What makes this important is the size. In the past there was no heart pump that was small enough for a child under 10. This pump is small enough for a newborn.
Derrick Hernandez, 13, owes his life to the Berlin. He got one in August while awaiting a heart transplant.
He said, "Like a week before I came to the hospital, I was weak and I couldn't do nothing. And when I got the Berlin, I felt like I could do more."
With the Berlin heart, the pumping mechanism sits outside the chest, with only tubes implanted to carry blood into and out of the device. It also comes with a bulky external drive unit. But some experts believe it could become the standard of care for children whose chests are often too small for an implantable device.
Dr. Jeff Dreyer, a cardiologist at Texas Children's Hospital, explained, "We're able to, not only get them to transplant, but get them to transplant in a better physiologic state, or stronger than they might otherwise be."
Four months after getting his heart pump, Derrick received a human heart transplant. He's gained weight and is returning to a more active life. His mother is grateful.
"Everything that it did for him, I'd do it again," said Bonnie Fraga.
According to Texas Children's, 77% of patients on the Berlin heart have survived to transplant. Right now, the FDA allows doctors to use the device when there's no other option to save a life.
Christi Myers is ABC13's Healthcheck reporter