BiVACORAnnounced inTexas Heart Institute (THI) Completes First Artificial HeartBiVACOR TAHImplantation, which is FDA-approvedPart of the Early Feasibility Study (EFS)."The Texas Heart Institute is excited about the first breakthrough implantation of the BiVACOR TAH. As heart failure remains a leading cause of death worldwide, the BiVACOR TAH offers a beacon of hope for countless patients awaiting heart transplants. We are proud to be at the forefront of this medical breakthrough, collaborating with the expert teams from BiVACOR, Baylor College of Medicine, and Baylor St. Luke’s Medical Center to transform the future of heart failure treatment for this vulnerable population."---Joseph Rogers Texas Heart InstitutePresident and Chief Executive Officer
"I am extremely proud to have witnessed the first successful implantation of our TAH into a human. This achievement would not have been possible without the courage of our first patient and their family, the dedication of our team, and the expert collaboration of our colleagues at the Texas Heart Institute. Utilizing advanced MAGLEV technology, our TAH brings us closer to providing a much-needed option for end-stage heart failure patients who require support while awaiting a heart transplant. I look forward to continuing to the next phase of our clinical trial."---Daniel Timms, Founder and Chief Technology Officer of BiVACORHeart failure is an incurable disease, and patients with end-stage heart failure generally have a limited survival period.NoMore than 5 years. For patients with end-stage heart failure, the best solution is a heart transplant. Unfortunately, there are too few hearts available for transplantation—less than 6,000 per year—and essentially only the elite and wealthy have the opportunity to undergo the procedure. Meanwhile, in the U.S. alone, over 100,000 heart failure patients need an immediate heart transplant each year. To address this scarcity of donor hearts, it becomes necessary to develop mechanical hearts that can serve as alternatives to human hearts.At present, the total artificial heart has become a hot spot for development, with multiple enterprises in China and abroad involved in its development.Total artificial heart. However, commercializing an artificial heart is an extremely difficult process. Even the relatively simpler left ventricular assist device faces various challenges during commercialization.All kinds of problems. For example, Medtronic's Heartware had to be withdrawn from the market due to quality issues, and Abbott's HeartMate 3 has also been plagued with problems (frequent recalls).
Currently commercializedTotal artificial hearts are very rare and are all used as bridge products for heart transplantation. For exampleCARMAT's Total Artificial HeartAeson（The LongestCan be implanted180 Days). AndBiVACORDevelopedBiVACOR TAHThe goal is to provide patients with a permanent implant to address the "hard-to-find heart" issue.Of course, considering the commercialization issues,BiVACOR TAHThis clinical study, like Aeson, involves short-term implantation as a bridge-to-transplant technology.
BiVACOR TAHIt is a long-term implantable total artificial heart, possessing all the functions of a human natural heart, thus completely replacing the patient's own heart. BiVACOR TAH isCompactTightCobbled togetherEquipment, smaller than a can of cola (60×φ70mm), with a weight of only 512 grams (slightly heavier than an adult human heart). DespiteBiVACOR TAHSmall, but capable of pumping the required blood volume for the patient.
BiVACOR TAHThe core technology lies in the internalMagnetic Levitation Rotor,Magnetic LevitationTurnSonThe principle is similar to the magnetic levitation driving method of maglev trains.。BiVACOR TAHThe key to fully replacing the heart lies in the left and right impeller blades, which are mounted on either side of the rotating hub. The hub is suspended and rotated by an electromagnetic motor and bearing assembly at the top of the pump housing. The impeller's specialized hydraulic design, combined with state-of-the-art magnetic levitation (MAGLEV) technology, allows for precise control of circulation through differential fluid output.Each side can pump more than 15 liters of blood per minute, meeting the needs of patients who want to engage in moderate exercise.BiVACOR TAHIn addition to the "magnetic levitation" technology, there is also a very important flow balance system that allowsBiVACOR TAHDynamic adjustment based on changes in the patient's physiological condition.Compared with other total artificial hearts,BiVACOR TAHThrough 3DManufactured using printing technology, its material is titanium, which has been clinically verified and exhibits excellent biocompatibility. The specially designed pump body with large gaps can effectively reduce blood cell damage and lower the risk of thrombosis.BiVACOR TAHDue to the adoption of "magnetic levitation" technology, internal part friction or mechanical wear is avoided, giving it a longer lifespan of at least 10 years. (Currently available artificial hearts are mostly used as a transitional technology before heart transplantation, rather than a true heart replacement.)BiVACOR TAH Demonstration
BiVACORIs an innovative medical device company established in 2008.BiVACORCommitted to addressing unmet needs in the field of heart failure, enabling patients with heart failure to recover from the disease. It is currently under development.BiVACORTotal Artificial Heart (TAH), the first long-term treatment option for patients with severe heart failure. The TAH is designed to fully replace the function of the native heart and address the unmet global need of end-stage heart failure (HF) patients by providing a next-generation life-extending solution.
