BiVACOR artificial heart earns FDA Breakthrough Device status

BiVACOR artificial heart: ©BiVACOR

BiVACOR, a Texas-based medical device company developing a next-generation Total Artificial Heart (TAH), has received Breakthrough Device Designation from the U.S. Food and Drug Administration, the company announced.

The designation supports the BiVACOR TAH as a bridge to transplant for adults with severe biventricular or univentricular heart failure who cannot be helped by current therapies, such as left ventricular assist devices. It also fast-tracks regulatory interaction and approval for medical devices that may significantly improve outcomes for patients with life-threatening conditions.

“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 Daniel Timms, PhD, BiVACOR’s founder and chief technology officer.

The announcement follows positive early results from BiVACOR’s FDA Early Feasibility Study, which began in July 2024. Five patients received the implant in the first phase. With encouraging safety and performance data, the FDA has now approved an expansion of the trial to include 15 more patients later this year.

BiVACOR’s TAH uses a single, magnetically levitated rotor to power both sides of the heart, mimicking natural heartbeat function without valves or mechanical wear points. The design allows for long-term durability, less blood trauma, and a more compact fit for both men and women.

“The early results are remarkable with no strokes, no device-related complications, and a safety profile unlike anything in this space,” said William Cohn, BiVACOR’s chief medical officer and a heart surgeon at the Texas Heart Institute. “With Breakthrough status in hand, we’re entering the next phase with the wind at our backs.”

More than 6 million Americans live with heart failure, and many progress to biventricular failure. Yet fewer than 4,500 heart transplants are performed annually in the U.S., highlighting the need for alternatives like BiVACOR’s investigational device.

Artificial heart innovation accelerates

BiVACOR’s TAH announcement adds to a growing wave of activity in the artificial heart sector as developers race to fill the growing gap between heart failure cases and transplant availability.

In late 2024, French company Carmat resumed European implants of its Aeson bioprosthetic heart following a suspension due to supply chain issues and device reliability concerns. Aeson remains one of the only other total artificial hearts to receive conditional commercial approval in Europe.

Meanwhile, SynCardia Systems continues to develop its next-generation TAH, building on its legacy pneumatic device approved for use as a bridge to transplant. The company has focused on expanding access through smaller pump sizes and wearable drivers.

These developments underscore a shifting landscape in mechanical circulatory support, as emerging devices seek to improve on the durability, size, and quality-of-life tradeoffs that have limited earlier generations.

While BiVACOR’s device is still investigational, its magnetically levitated rotor and compact design represent a significant technological departure from past models—one that could eventually redefine long-term heart replacement therapy, according to industry experts.