Heart failure is a global epidemic affecting at least 26 million people worldwide, 6.2 million adults in the U.S., and is increasing in prevalence. Heart transplantations are reserved for those with severe heart failure and are limited to fewer than 6,000 procedures per year globally.

Consequently, the U.S. National Institutes of Health estimated that up to 100,000 patients could immediately benefit from mechanical circulatory support (MCS), and the European market is similarly sized. Without intervention, patients with severe HF have a bleak outlook. For these patients, drug therapy is a limited, relatively ineffective option. Although a heart transplant would meet their needs, only 6000 donor hearts are available globally each year.

Implantation of a Total Artificial Heart (TAH) is a treatment option for patients with end-stage biventricular HF who need support while on a heart transplant waiting list. Removal of the native ventricles allows the device to completely replace the function of the native heart.

BiVACOR is conducting an FDA-approved, first-in-human, Early Feasibility Study (EFS) that aims to evaluate the safety and performance of the BiVACOR TAH as a bridge-to-transplant solution for patients with severe biventricular heart failure or univentricular heart failure in which left ventricular assist device support is not recommended.

The First-in-Human implantation of the BiVACOR TAH was completed on July 9, 2024, at Baylor St. Luke’s Medical Center in the Texas Medical Center. A total of five patients will be treated under the design of the FDA-approved IDE Early Feasibility Study.

The BiVACOR TAH represents a paradigm shift in artificial heart design. Current TAH technologies utilize volume displacement pump designs with flexible polymer diaphragms to pump the blood. In contrast, the BiVACOR TAH is an electro-mechanical rotary blood pump. The primary design innovation in the BiVACOR TAH is its simple construction, with one motor and a single magnetically levitated rotor that simultaneously pumps blood to both the body and the lungs.

The BiVACOR Total Artificial Heart (TAH) combines centrifugal rotary pump and magnetic levitation (MAGLEV) technologies to produce a biventricular blood pump with a novel single pump rotor that pumps blood to the systemic (body) and pulmonary (lung) circulations to replace both ventricles of a failing heart.

The dual-sided rotor, with unique impeller designs on each side, is magnetically levitated between two separate pump chambers of the TAH. The double-sided centrifugal impeller propels blood from the respective pump chambers to the pulmonary and systemic circulations.

Investigational Device. Limited to Investigational Use Only in The United States.

The BiVACOR TAH is designed to be a long-term device that can replace the total function of the patient’s native heart. The small, compact device uses proven rotary blood-pump technology to provide the required cardiac output.

The BiVACOR system comprises a magnetically levitated rotor located between opposing pump casings. The key feature that enables this device to support both the left and right sides of the heart is the left and right impeller blades, which are mounted on either side of the rotating hub. The hub is levitated and rotated via an electromagnetic motor and bearing arrangement on top of the pump casings. The dedicated hydraulic design of the impellers, combined with state-of-the-art magnetic levitation (MAGLEV) technology, permits control of the circulation to be fine-tuned by means of a differential fluid output.

An external controller and batteries provide power to the internal device via a percutaneous driveline.

BiVACOR® is a clinical-stage medical device company pioneering the development of a long-term therapy for patients with biventricular heart failure. Under the expert direction of its founder and TAH inventor, Daniel Timms, PhD, and the guidance of two luminaries in cardiovascular surgery, William E. Cohn, MD, and O.H. (Bud) Frazier, MD, the BiVACOR TAH is currently undergoing an FDA-approved first-in-human Early Feasibility Study (EFS). Headquartered in Huntington Beach, California, with clinical offices in Houston, Texas, and international offices in Gold Coast, Australia, BiVACOR is committed to addressing the global unmet need of patients with end-stage heart failure awaiting transplant by providing the next generation of life-extending solutions.

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BiVACOR is always accepting applications for motivated engineers and scientists.

Please send us your application documents via the career page or at Careers@BiVACOR.com