Berlin Heart Receives FDA Approval Following Clinical Study at St. Louis Children’s and Washington University School of Medicine
The ability to rescue children from heart failure has dramatically improved with the FDA approval of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device. The device functions as a ‘bridge to transplant’ for children ranging in age from newborn to teenagers, pumping blood in place of the failing heart and buying time until a donor heart becomes available.
“With the Berlin, we can salvage children who would have otherwise died waiting,” says Dr. Charles Canter, Medical Director of the Pediatric Heart Transplant Program at St. Louis children’s Hospital and Washington University School of Medicine.
Because of its high volume of transplant patients, St. Louis Children’s Hospital had the opportunity to begin implanting the device under “compassionate use” terms in 2006. Those successful outcomes in St. Louis, as well as handful of other high-volume pediatric centers, paved the way for a 15-center clinical trial which included St. Louis Children’s Hospital/Washington University School of Medicine.
The FDA approval makes the Berlin heart the only ventricular assist device designed specifically for the pediatric population available in the United States.
“Before the Berlin heart, if a child was in heart failure and required ECMO (bypass), we knew they could only survive on that machine for 14 days. It was a race against the clock,” says Dr. Canter. “As a result, we were forced to take organs that were less than perfect.”
Being hooked up to the ECMO machine and a ventilator also meant the child was immobilized, or even paralyzed in the intensive care unit preceding transplant. Because of his weakened condition, recovery was much more challenging following the transplant.
“But on the Berlin,” says Canter, “they’re able to get up and walk and eat and stay strong while they wait for their transplant.
The average hospital stay following a heart transplant was 4-6 weeks before the Berlin heart was available. Today, the average transplant patient leaves St. Louis Children’s Hospital within 7-10 days.
“They get better so quickly and go back to their normal lives so much sooner than before the device.”
The Berlin Heart not only bridged these two boys to transplant, it connected them in friendship for life.