US-based medical device company BiVACOR has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for its Total Artificial Heart (TAH).
TAH is being developed as a bridge to transplant for patients with severe heart failure.
It is intended for adults with severe biventricular or univentricular heart failure where current treatments, such as LVADs, are not viable.
The first phase of the early feasibility study was completed, where five US patients received the TAH between July and November last year.
The US regulator approved expanding the trial to include 15 more patients later this year, based on positive safety and performance data from the initial phase.
The FDA’s Breakthrough Device programme is designed for technologies that can potentially enhance outcomes for patients with life-threatening conditions.
The designation provides priority regulatory interaction and accelerated approval pathways.
BiVACOR founder and chief technology officer Daniel Timms said: “This is more than a regulatory milestone. It’s a validation of a concept we’ve spent decades proving that a fully implantable, total artificial heart isn’t just possible, it’s necessary.
“Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies.
“The Breakthrough Device Designation puts us on a faster track to deliver exactly that.”
BiVACOR has designed the TAH to be compact enough for most men and women, and introduces a novel category in artificial heart technology.
The device leverages magnetic levitation to suspend a single dual-sided rotor, powering both the right and left circulatory systems.
Its design mimics the natural heartbeat without valves or mechanical wear points, offering pulsatile flow, reduced trauma, and long-term durability.
The BiVACOR TAH remains investigational and is not yet approved for commercial use.
BiVACOR chief medical officer William Cohn said: “We’ve seen every kind of artificial heart technology over the last four decades, but this is the first system I’ve encountered that combines engineering elegance, efficiency, and safety with true clinical viability.
“The early results are remarkable with no strokes, no device-related complications, and a safety profile unlike anything in this space. With Breakthrough status in hand, we’re entering the next phase with the wind at our backs and real momentum to bring this to more patients.”
Last year, surgeons at The Christ Hospital Health Network completed the fourth human implantation of the BiVACOR TAH worldwide.
