BiVACOR Announces FDA Approval to Expand Clinical Study of BiVACOR Total Artificial Heart Following Successful First-in-Human Feasibility Phase

Dec 19, 2024 22:15 CST Updated 22:15

BiVACOR

Preclinical Artificial Heart Device Developer

BiVACORAnnouncing the completion of the first phase of the FDA-approved early feasibility study (5 patients received treatment between July and November 2024).BiVACOR TAHTreatment).The first phase of the early feasibility study aims toEvaluatedBiVACOR TAHSafety and Product Performance of BiVACOR as a Bridge to Heart Transplantation in Patients.

First Stage: Successful Implantation in an Unnamed PatientBiVACOR TAH, andBiVACOR TAHProviding support for these patients for up to a month. Subsequently, these patients underwent heart transplantation and were discharged. The phase I clinical data was submitted for FDA approval.BiVACOR TAHProviding a basis for expanding the scope of research, the FDA eventually agreed toThe early feasibility study involved an increase in the number of patients from 5 to 20. NextBiVACOR TAHWill provide treatment for the subsequent 15 heart failure patients.

PI Evaluation

"It's incredible to see our device provide such efficient support for the first group of American patients. The unique design and functionality of the BiVACOR TAH translate into unparalleled safety, with no complications or strokes. Now that the first five patients have been implanted, we will continue to work with the FDA to provide the necessary data for expanding our EFS study."

---William Cohn Texas Heart Institute

Executive Evaluation

"We are pleased to announce that the first patients implanted with the BiVACOR TAH have achieved the expected milestones using the device as a bridge to heart transplantation, and no complications have occurred. This research has been ongoing for decades, and such success in the first human trials is highly encouraging. We are extremely grateful to all the participating patients, their families, and clinical partners. Without them, we could not have made the TAH available to those who need it most."

---Daniel Timms Founder and Chief Technology Officer of BiVACOR

BiVACOR TAH

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 LevitationTurnChildThe 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 located at the top of the pump housing. The specialized hydraulic design of the impeller, combined with state-of-the-art magnetic levitation (MAGLEV) technology, allows for fine-tuned 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 balancing 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, the 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 parts' 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

BiVACOR

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 for patients with severe heart failure. The TAH is designed to replace the full 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.