The US Food and Drug Administration (FDA) has granted breakthrough device designation to BiVACOR鈥檚 titanium Total Artificial Heart (TAH), as a potential bridge to transplant for the adult population with severe heart failure, where current treatments are insufficient.
This designation comes after the initial phase of the FDA’s early feasibility study, with five American patients receiving the TAH between last July and November.
The agency has approved the trial expansion to include an additional 15 subjects, commencing later this year, based on the encouraging performance and safety data from the study.
BiVACOR noted that the TAH utilises magnetic levitation to suspend a dual-sided rotor, powering both the right and left circulatory systems of the heart and emulating a natural heartbeat without the need for valves or mechanical wear points.
It is still investigational and not yet approved for use commercially.
BiVACOR CTA and founder Daniel Timms said: 鈥淭his is more than a regulatory milestone. It鈥檚 a validation of a concept we鈥檝e spent decades proving that a fully implantable, total artificial heart isn鈥檛 just possible, it鈥檚 necessary.
US Tariffs are shifting - will you react or anticipate?
Don鈥檛 let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData鈥淧atients 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.鈥�
The implantable device is designed to be compact enough to fit most adults and offers the potential for pulsatile flow, large blood gaps to minimise trauma, and long-term durability.
According to the company, heart failure impacts over six million Americans, and many individuals progress to irreversible biventricular failure each year.
The FDA’s breakthrough device programme is intended for solutions that could improve patient outcomes in life-threatening or irreversibly debilitating conditions. It provides devices with priority regulatory interaction and expedited approval pathways.
Last year, the Texas Heart Institute successfully implanted BiVACOR’s TAH in a human patient.
