FDA approval to begin studies and enroll 10 patients with end-stage biventricular heart failure—people who are suffering on the waiting list for a heart donor—and offer a life-saving bridge before transplant.

Carmelo Milano, a transplant surgeon and the principal investigator of the device study at Duke.

Meanwhile, Duke was among just three transplant centers in the United States selected to join the device study, and the procedure team received specialized training to prepare for the implant surgery.

If the device receives FDA approval, it would provide hope for transplant patients whose hearts require assistance to pump blood through both chambers.

“Because of the shortages of donor hearts, many patients die while waiting for a heart transplant,” said Schroder, a transplant surgeon who led the implant procedure