Feasibility Testing of the 2nd Generation Inspired Therapeutics NeoMate System for Paracorporeal Support of Neonates and Infants in Heart Failure.

Abstract

Background: Inspired Therapeutics is advancing the development of the next generation of the NeoMate mechanical circulatory support (MCS) system for neonate and infant heart failure (HF) populations. The NeoMate system includes a low-cost magnetically-actuated paracorporeal centrifugal pump with an integrated, reusable motor and controller. This design iteration features a compact size (37 mm diameter), small prime volume (10 mL), and redesigned rotor and flow path. We present experimental data from computational fluid dynamics (CFD), mock loops, and acute animals.

Methods: CFD models were used to improve pump design (wall shear stress, hemolysis index) and motor performance (torque, power, efficiency). Static mock loops (3.5 cP) were performed to evaluate hydrodynamics over a range of loads (0-300 mmHg) at 500-5500 rpm (n = 2 pumps tested, 24Fr inflow and 16Fr outflow cannula). A dynamic mock loop (3.5 cP) was tuned to HF, with the pump integrated LV apex-to-aorta and data collected from 0 to 5500 rpm. Two acute sheep studies were performed with each pump implanted paracorporeally: one LV apex-to-aorta (24Fr inflow, 16Fr outflow) and the other via the jugular vein (28Fr dual-lumen cannula).

Results: CFD pump and motor performance and hemolysis index metrics were achieved exceeding design criteria (2.5 L/min, 150 mmHg) in static (2.5 L/min flow, 250 mmHg pressure), dynamic (2.8 L/min flow), and animals (3.1 L/min flow, 60 mmHg aortic pressure, plasma free hemoglobin < 20 mg/dL) at 5500 rpm.

Conclusions: The next generation NeoMate pumps demonstrated favorable hydrodynamic, hemodynamic, and blood trauma performance, showing promising progress toward this technology to serve as a versatile therapy for neonates and infants.