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The Inspired Therapeutics Neomate MCS System for Neonates and Infants

In May 2022, scientists from the University of Louisville (Departments of Cardiovascular and Thoracic Surgery, Bioengineering, Anesthesiology, and Perioperative Medicine), Veritium research LLC

In May 2022, scientists from the University of Louisville (Departments of Cardiovascular and Thoracic Surgery, Bioengineering, Anesthesiology, and Perioperative Medicine), Veritium research LLC, and Inspired Therapeutics LLC tested the NeoMate mechanical circulatory support (MCS) system for neonates and infants. The complete manuscript by Gretel Monreal, Steven C. Koenig, Mark S. Slaughter, Gino F. Morello, Steven R. Prina, Landon H. Tompkins, Jiapeng Huang, Barry N. Gellman, and Kurt A. Dasse can be found in Plos One. Their research is summarized below.

Up to 14,000 US children are hospitalized yearly with heart failure (HF)-related conditions. These children show a mortality rate of 7-15%, while the mortality rate of those on the waiting list for a heart transplant ranges from 5-39%. Because of these statistics, temporary and durable mechanical circulatory support devices prove to be important in supporting this patient population.

There are many limitations in current MCS technology, including:

  • challenges surrounding the reduction of adult-size pumps to fit the smaller bodies of the neonate and infant populations
  • complex implant and management strategies
  • potentially challenging cannula configurations that may need to work in the presence of congenital cardiac anomalies
  • cost-effectiveness
  • risk reduction

Inspired Therapeutics is developing the NeoMate System, a novel MCS therapy that will operate a family of interchangeable, single-use, extracorporal, magnetically levitated pumps designed for multiple clinical indications.

Monreal et al. developed and fabricated three Inspired Therapeutics NeoMate System prototypes and performed testing in dynamic mock flow loops, static mock flow loops, and acute animals. The data collected from this testing showed that the system could function over a range of rotary pump speeds, provide pump flow rates up to 2.6 L/min, and unload volume in the left ventricle of acute animals. Additionally, no device or controller failures occurred during the experimental testing.

In conclusion, this research demonstrates a novel MCS technology for neonate and infant populations. There were some limitations and challenges identified, which will be addressed with future testing, such as necessary design improvements and operation challenges, including thoroughly and efficiently de-airing the pump, tubing, and cannulae and removing mechanical vibrations and noise at higher pump speeds.

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For further reading, the complete manuscript by Monreal et al. can be found in Plos One.

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