Revolutionizing cardiac care, the BiVacor Total Artificial Heart (TAH) progresses to expanded trials following promising early results.
A Milestone in Artificial Heart Development
BiVacor has completed the first phase of its FDA early feasibility study (EFS) for the Total Artificial Heart. Key achievements include:
- Five successful implants: Patients with severe biventricular failure supported between July and November 2024.
- One-month support period: Enabled patients to await donor heart transplants.
- Positive outcomes: All patients discharged without complications or strokes.
These results led the FDA to approve the enrollment of an additional 15 patients in the next phase of the EFS.
Innovative Technology Leading the Way
The BiVacor TAH is designed to fully replace the heart’s function. Notable features include:
- Magnetic levitation technology: A single moving part with a double-sided impeller reduces wear and blood trauma.
- Pulsatile outflow: Mimics natural heartbeats through advanced rotor cycling.
- Compact and efficient: Comparable to an adult fist, yet capable of sustaining cardiac output during exercise.
Transforming Heart Transplantation
Dr. William Cohn, BiVacor’s Chief Medical Officer, highlighted the groundbreaking nature of the device:
“Our design has achieved exceptional safety without complications, marking a pivotal step in cardiac care.”
Founder and CTO Daniel Timms added:
“This success reflects decades of innovation and offers hope for patients needing heart transplants.”
Next Steps for the BiVacor TAH
With FDA approval for expanded trials, BiVacor will further assess the device’s safety and effectiveness, bringing it closer to clinical availability as a life-saving bridge to heart transplantation.
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