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# Breakthrough Status for Artificial Heart
- URL: https://www.fdaweb.com/breakthrough-status-for-artificial-heart/
- Published: 2025-05-30T12:00:00.000Z
- Updated: 2026-09-14T15:13:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159278

FDA has granted BiVACOR a breakthrough device designation for its titanium Total Artificial Heart (TAH). The designation supports the BiVACOR TAH as a bridge to transplant (BTT) for adults with severe biventricular or univentricular heart failure where current treatments, including a left ventricular assist device, are not viable, according to the company.

“Patients with biventricular failure have been overlooked for too long,” the company says. Based on data from a five-patient feasibility study, FDA has approved the expansion of the trial to include 15 additional patients starting later this year.

The compact device is small enough to fit most men and women, the company says. “The TAH uses magnetic levitation, similar to maglev trains, to suspend a single dual-sided rotor,” it says. “This rotor simultaneously powers the right and left circulatory systems, mimicking the natural heartbeat without valves or mechanical wear points. Its simplified design allows for pulsatile flow, large blood gaps to reduce trauma, and long-term durability.”