BiVACOR’s Total Artificial Heart Wins FDA Breakthrough Nod

BiVACOR has received U.S. Food and Drug Administration (FDA) breakthrough device designation for its world-first titanium Total Artificial Heart (TAH).

The designation supports the BiVACOR TAH as a bridge-to-transplant (BTT) for adult patients with severe biventricular or univentricular heart failure where current treatments (including LVADs) aren’t viable.

This milestone comes after the first phase of the company’s FDA early feasibility study, where five patients received the TAH between July and November 2024. The FDA approved the trial’s expansion to 15 additional patients, which will start later this year, based on positive safety and performance data.

The artificial heart is compact enough to fit most women and men, according to the company. It uses magnetic levitation to suspend a single dual-sided rotor. The rotor powers the right and left circulatory systems, mimicking a natural heartbeat without using valves or mechanical wear points.

The company said its design allows for pulsatile flow, large blood gaps to reduce trauma, and long-term durability.

“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,” said BiVACOR founder and chief technology officer Daniel Timms, Ph.D. “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.”

“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,” added William Cohn, MD, BiVACOR’s chief medical officer and a heart surgeon at the Texas Heart Institute. “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.”