Replacing Hearts.
Restoring Lives.
HEART FAILURE
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.
Total Artificial Heart Therapy
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.
First-in-Human Early Feasibility Study
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.
DEVICE
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.
Powerful
Capable of providing high flows over 12 L/min, enough cardiac output for an adult male undergoing exercise
Smart
Pump operation is driven by a smart controller that adapts to changes in patient activity and cardiac output demand.
Durable
No valves, no flexing ventricle chambers or pumping diaphragms, and no mechanical bearings. Non-contact suspension of the pump rotor via magnetic levitation (MAGLEV) eliminates mechanical wear within the pump.
Constructed from titanium based on its material properties of high biocompatibility, corrosion resistance, and strength.
Small
The implantable TAH is compact and suitable in size for most men and women (Body Surface Area >1.4 m2).
Portable
A small external controller, combined with a rechargeable battery system, supports untethered operation from an AC power source to enhance patient mobility and freedom of movement.
TECHNOLOGY
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.
A Single Moving Part
A single, dual-sided impeller rotor pumps blood to both the systemic and pulmonary circulations.
Advantages of a Rotary Pump
Specially designed pump impellers are capable of producing high physiological blood flows with low power consumption. Pulsatile flow is produced with cyclic speed modulation of the centrifugal pump rotor.
Physiologic Interaction
A patented left-right flow-balancing system allows dynamic adaptation to changes in the patient’s hemodynamic physiology.
Active Magnetic Levitation (MAGLEV) Technology
The pump has no mechanical bearings. MAGLEV suspension of the rotor provides precise, stable operation with no friction or mechanical wear.
Blood Compatibility
All blood flow paths have large clearance gaps to reduce shear forces and blood trauma and avoid blood stagnation within the pump.
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.
ABOUT US
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.
MEET THE TEAM
We are all around the world!
Daniel Timms, PhD
Founder & Chief Technical Officer
Dr. Daniel Timms, an innovative biomedical engineer, is the founder and technological driving force behind the groundbreaking BiVACOR Total Artificial Heart. His journey began in Brisbane, Australia, where he spent countless hours alongside his plumber father, tinkering with water pumps and constructing imaginative devices. A personal tragedy ignited Dr. Timms’ unwavering commitment to revolutionize cardiovascular care.
A graduate of Queensland University of Technology, Dr. Timms’ research journey took him from Brisbane’s Prince Charles Hospital to prestigious institutions worldwide. Collaborating with Germany’s Helmholtz Institute—one of Europe’s foremost cardiovascular engineering research centers—and The Texas Heart Institute, he contributed to groundbreaking work in TAH design and development. In 2023, he received a nomination for Queensland’s “Australian of the Year” Award.
Today, Dr. Timms continues to collaborate with global experts to develop cutting-edge cardiovascular medical devices. His unwavering dedication underscores his pivotal role in advancing cardiac care and saving lives.
William Cohn, MD
Chief Medical Officer
Dr. William “Billy” E. Cohn is the Chief Medical Officer of BiVACOR®. He is also the Executive Director of the CDI@TMC, the Center for Device Innovation at The Texas Medical Center, a Tenured Professor of Surgery at Baylor College of Medicine, and a staff cardiothoracic surgeon at the Texas Heart Institute.
Dr. Cohn earned an undergraduate degree in Biology and Chemistry from Oberlin College in Ohio and went on to receive his Doctor of Medicine from Baylor College of Medicine in Houston. He completed seven years of general surgical and cardiothoracic surgical training at the Baylor College of Medicine Affiliated Hospitals and a one-year cardiothoracic fellowship at Boston’s Beth Israel Hospital. After completing his training, Dr. Cohn served as a staff Cardiothoracic surgeon at the Beth Israel Deaconess Medical Center and as a faculty member of the Harvard Medical School for ten years before returning to Houston.
Medical device development remains Dr. Cohn’s passion. He has been granted more than 90 U.S. patents or patents pending for his medical innovations that have provided the core technology for six venture-backed medical start-ups.
Dr. Cohn’s numerous awards include the 2023 Bakken Scientific Achievement Award from the Society of Thoracic Surgeons, an honorary Doctorate in Science from Oberlin College, the Distinguished Scientist Award, given by the MacDonald Fund, and the Edison Award for excellence in human-centered design and innovation for the SentreHEART® Lariat®. In 2000, Dr. Cohn was named the distinguished Inventor of the Year by the U.S. Intellectual Property Owners Association. In 2014, he was named Outstanding Inventor of the Year by the Houston IPO. In addition, he received the Innovation Award at ICI in Tel Aviv for inventing the TVA everLINQ system and the Octane Cardiovascular Innovation award in 2023. In 2015, he was awarded a Lifetime Achievement Award for healthcare innovation by the Houston Technology Center.
CAREERS
BiVACOR is always accepting applications for motivated engineers and scientists.
Please send us your application documents via the career page or at HR@BiVACOR.com
GALLERY
