Bivacor Earns FDA Breakthrough Status for Artificial Heart

Bivacor has received FDA breakthrough designation for its titanium total artificial heart, a compact device with just one moving part—a magnetically suspended rotor. Unlike traditional designs, it eliminates valves, diaphragms, and mechanical bearings, reducing friction and wear.

The heart supported five U.S. patients for up to a month as a bridge to transplant. All received donor hearts and were discharged. In Australia, one patient lived 105 days with the device and was the first to go home while awaiting a transplant.

The FDA has approved Bivacor to enroll 15 more patients in its ongoing feasibility study. Though used short-term so far, the device is designed for longer-term use, even during physical activity.

Bivacor joins a competitive field with Syncardia, Realheart, and Carmat also developing total artificial hearts.

11-06-2025