FDA sees promise in new total artificial heart technology, granting it ‘breakthrough’ status
BiVacor has received the FDA’s breakthrough device designation for its titanium Total Artificial Heart (TAH), which serves as a bridge to transplant for patients with end-stage heart failure.
BiVacor’s TAH is based on rotary blood pump technology and approximately the size of an adult’s fist. It has no valves or flexing ventricle chambers, and its only moving part is a magnetically suspended double-sided centrifugal pump impeller.
The FDA’s decision signals just how much potential the agency sees in this technology. The breakthrough devices program is designed to help medical devices make it through the approval process faster than they would otherwise. Its representatives work directly with the manufacturer, for example, and submissions are prioritized.
BiVacor founder Daniel Timms, PhD. Image courtesy of BiVacor.
“This is more than a regulatory milestone,” Daniel Timms, PhD, founder and chief technology officer of BiVacor, said in a statement. “It’s a validation of a concept we’ve spent decades proving that a fully implantable, TAH 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.”
The FDA’s decision was based largely on early data from an early feasibility study. The study was originally designed to include five patients, but it was expanded to include an additional 15 patients in late 2024. Those first five patients all successfully received a BiVacor,TAH and then waited for up to a month before eventually undergoing a heart transplant. The other 15 patients are scheduled to start receiving their devices in the months ahead.
“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,” William Cohn, MD, BiVacor’s chief medical officer and a heart surgeon at the Texas Heart Institute, said in the same statement. “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.”
The BiVacor has still not gained full FDA approval, so it is not yet available for commercial use in the United States.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.