The BiVACOR Total Artificial Heart (TAH) System is designed as a short- and long-term implantable replacement option for the failing human heart. The device combines rotary blood pump and magnetic levitation technology to produce a single, contact-free, spinning disc that reliably and efficiently pumps blood to the systemic and pulmonary circulations. Rapid and cyclic changes in pump speed induce pulsatile outflow, while large blood gaps reduce stress on the blood. The system is electrically powered by a small, external, portable controller that connects to the pump via a small, single percutaneous driveline. The compact design of the BiVACOR TAH System expands its use for implantation in women and children. However, the small pump size does not compromise physiological capability, with the BiVACOR TAH System sufficiently powerful to support an adult male during exercise. Several BiVACOR TAH System iterations have been produced over the last 20 years, which have been implanted in over 30 chronic animal studies for up to 3 months. Further, BiVACOR pumps have operated uninterrupted in benchtop studies for over 4 years (ongoing). BiVACOR have achieved significant progress, completing key milestones in the development, manufacturing, and evaluation of the clinical-grade BiVACOR TAH System. With its reliable, safe, and blood-friendly design, the BiVACOR TAH System has the potential to provide long-term heart replacement to an expanded patient population.

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BiVACOR Total Artificial Heart and Future Concepts

  • Matthias Kleinheyer,
  • Nicholas Greatrex,
  • Frank Nestler,
  • Daniel L. Timms

摘要

The BiVACOR Total Artificial Heart (TAH) System is designed as a short- and long-term implantable replacement option for the failing human heart. The device combines rotary blood pump and magnetic levitation technology to produce a single, contact-free, spinning disc that reliably and efficiently pumps blood to the systemic and pulmonary circulations. Rapid and cyclic changes in pump speed induce pulsatile outflow, while large blood gaps reduce stress on the blood. The system is electrically powered by a small, external, portable controller that connects to the pump via a small, single percutaneous driveline. The compact design of the BiVACOR TAH System expands its use for implantation in women and children. However, the small pump size does not compromise physiological capability, with the BiVACOR TAH System sufficiently powerful to support an adult male during exercise. Several BiVACOR TAH System iterations have been produced over the last 20 years, which have been implanted in over 30 chronic animal studies for up to 3 months. Further, BiVACOR pumps have operated uninterrupted in benchtop studies for over 4 years (ongoing). BiVACOR have achieved significant progress, completing key milestones in the development, manufacturing, and evaluation of the clinical-grade BiVACOR TAH System. With its reliable, safe, and blood-friendly design, the BiVACOR TAH System has the potential to provide long-term heart replacement to an expanded patient population.