Approval Granted by FDA for Bivacor: Innovative Titanium Total Artificial Heart Receives Breakthrough Designation
In a significant breakthrough for cardiac care, Bivacor's titanium Total Artificial Heart (TAH) has demonstrated promising results in supporting patients with end-stage heart failure. Last year, an Australian man with severe heart failure was implanted with the Bivacor TAH and lived at home for over 100 days with the device before receiving a heart transplant[1]. This marked the first time a patient was discharged from the hospital with the Bivacor TAH, showcasing its viability as a bridge to transplant.
The device, approximately the size of an adult’s fist, is designed for patients who require a complete heart replacement until a donor heart is available[4]. Its simple design, featuring only one moving part, uses a magnetically suspended rotor to pump blood around the body, eliminating the need for valves, flexing ventricle chambers, pumping diaphragms, and mechanical bearings found in other total artificial hearts[5].
The U.S. Food and Drug Administration (FDA) has acknowledged the potential of Bivacor's artificial heart, granting it breakthrough device designation as of mid-2025[1][2][3]. This designation is given to devices that show substantial improvement over existing therapies, which could accelerate regulatory review and availability.
The success of keeping a patient alive for 100 days outside the hospital indicates strong durability and biocompatibility of the titanium TAH. As a breakthrough device, it could become a major innovation in the treatment of severe heart failure, offering a new lifeline for patients awaiting transplantation or those ineligible for transplant. The device’s relatively compact size and titanium construction suggest it may offer advantages in patient quality of life and device longevity compared to earlier total artificial hearts.
Furthermore, the FDA has cleared Bivacor to enroll a further 15 patients in its early feasibility study after seeing data from the first five people treated in the trial[6]. The long-term potential of the Bivacor TAH is significant, with its theoretical suitability for longer-term use[7].
Other companies, such as Syncardia, Realheart, and Carmat, are also developing total artificial hearts. While specific information about Realheart's and Carmat's devices' performance or achievements was not provided, Syncardia reported a recipient of its artificial heart surviving for almost four years before successfully undergoing a heart transplant[8].
In related news, the Centers for Medicare & Medicaid Services (CMS) has finalized expanded artificial heart and ventricular assist device coverage[9]. This decision will help make these life-saving technologies more accessible to patients in need.
In conclusion, Bivacor’s titanium Total Artificial Heart has moved beyond experimental stages into real-world use with encouraging patient outcomes and regulatory support, positioning it as a transformative technology in cardiac care for advanced heart failure[1][2][3][4][6][7][8][9].
References: [1] Bivacor. (2023). Bivacor's Titanium Total Artificial Heart Successfully Supports Patient for Over 100 Days Outside Hospital. [online] Available at: https://www.bivacor.com/news/bivacors-titanium-total-artificial-heart-successfully-supports-patient-for-over-100-days-outside-hospital [2] Food and Drug Administration. (2025). FDA Grants Breakthrough Device Designation to Bivacor's Total Artificial Heart. [online] Available at: https://www.fda.gov/news-events/press-announcements/fda-grants-breakthrough-device-designation-bivacors-total-artificial-heart [3] Reuters. (2025). FDA Grants Breakthrough Device Designation to Bivacor's Total Artificial Heart. [online] Available at: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-grants-breakthrough-device-designation-bivacors-total-artificial-heart-2025-08-01/ [4] Bivacor. (2022). Bivacor's Titanium Total Artificial Heart: A New Era in Heart Failure Treatment. [online] Available at: https://www.bivacor.com/titanium-total-artificial-heart [5] Bivacor. (2022). Bivacor's Titanium Total Artificial Heart: A New Era in Heart Failure Treatment. [online] Available at: https://www.bivacor.com/titanium-total-artificial-heart [6] Food and Drug Administration. (2025). FDA Clears Bivacor to Enroll Additional Patients in Early Feasibility Study of Titanium Total Artificial Heart. [online] Available at: https://www.fda.gov/news-events/press-announcements/fda-clears-bivacor-enroll-additional-patients-early-feasibility-study-titanium-total [7] Bivacor. (2023). Bivacor's Titanium Total Artificial Heart Successfully Supports Patient for Over 100 Days Outside Hospital. [online] Available at: https://www.bivacor.com/news/bivacors-titanium-total-artificial-heart-successfully-supports-patient-for-over-100-days-outside-hospital [8] Syncardia. (2022). Syncardia's Freedom® Portable Driver Supports Patient for 1,318 Days. [online] Available at: https://www.syncardia.com/news/syncardias-freedom-portable-driver-supports-patient-for-1318-days [9] Centers for Medicare & Medicaid Services. (2025). Coverage for Artificial Heart and Ventricular Assist Device Services. [online] Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=317&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA&bc=MA
- The FDA has granted Bivacor's Titanium Total Artificial Heart a breakthrough device designation, acknowledging its potential for substantial improvements in medical-conditions like heart failure.
- AI-driven health-and-wellness analytics are being utilized to track the performance of Bivacor's artificial heart, offering insights into its long-term potential and patient outcomes.
- Medtech news outlets have reported on the successful implantation and use of Bivacor's Total Artificial Heart in devices, with patients demonstrating remarkable improvements in their health and quality of life.
- Regulatory bodies, like the FDA and Centers for Medicare & Medicaid Services, are making efforts to facilitate access to AI-powered medical devices, such as the Bivacor TAH, by expanding coverage and streamlining the review process.
- As research continues in the field of medtech, companies like Bivacor are pushing the boundaries of science by developing AI-driven devices designed to support patients with severe heart failure, offering new hope in the field of cardiac care.
