BiVacor revealed today that it has successfully concluded the initial phase of an FDA-sanctioned early feasibility study (EFS) for its Total Artificial Heart (TAH).
In this phase, the BiVacor TAH was implanted in five patients between July and November 2024, serving as a bridge to donor heart transplants. The system supported patients experiencing severe biventricular failure for up to a month while they awaited a donor heart. Following the successful implants and subsequent patient discharges, the FDA granted permission to expand the EFS to include 15 additional patients.
“Witnessing our device deliver such effective support to the first U.S. patients is incredibly gratifying,” commented Dr. William Cohn, BiVacor’s chief medical officer. “The distinctive design and features of the BiVacor TAH have resulted in a remarkable safety profile, free from complications or strokes. With the initial five implants completed, we remain committed to collaborating with the FDA to deliver the necessary data for further expansion of our EFS study.”
About the BiVacor TAH
The BiVacor TAH is engineered to fully replicate the functions of the natural heart. Measuring around the size of an adult fist, it features magnetic levitation technology. A common rotor that supports left and right vanes forms the only moving part, powered by a magnetically suspended double-sided centrifugal impeller. This design allows the device to create pulsatile blood flow by rapidly varying the impeller’s rotational speed. The non-contact suspension ensures large blood gaps, minimizing blood trauma and eliminating mechanical degradation.
Despite its compact size, the TAH can provide sufficient cardiac output for an adult male during exercise. It contains no valves or flexible ventricle chambers, instead achieving pulsatile flow by momentarily boosting the rotor speed every second.
The company obtained FDA investigational device exemption in November 2023 to commence a first-in-human study for this system.
Daniel Timms, the founder and chief technology officer of BiVacor, stated, “We are elated to announce that the initial BiVacor TAH patients have reached expected milestones with no complications while using the device as a bridge to heart transplant. This has been decades of effort, and reaching this level of success in early human trials is highly motivating. We owe a debt of gratitude to all the patients, their families, and our clinical partners, without whom bringing the TAH to those who need it most would not be possible.”