Evidence map›Paper›PMID 42049685›Full record

ArticleArtificial organs2026

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

Gretel Monreal, Steven C Koenig, Mark S Kelley, Joshua G Crane, Isabelle R Lytle, Jiapeng Huang, Mark S Slaughter, Daniel G White, Daniel Tamez, James F Kelley

Abstract read
In one paragraph

Article in Artificial organs, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Gretel MonrealDepartment of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky, USA.
Steven C KoenigDepartment of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky, USA.ORCID https://orcid.org/0000-0002-8348-6127
Mark S KelleyInspired Therapeutics LLC, Charlottesville, Virginia, USA.
Joshua G CraneDepartment of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky, USA.
Isabelle R LytleSchool of Medicine, University of Louisville, Louisville, Kentucky, USA.
Jiapeng HuangDepartment of Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, Kentucky, USA.
Mark S SlaughterDepartment of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky, USA.
Daniel G WhiteRand Simulation, Cleveland, Ohio, USA.
Daniel TamezInspired Therapeutics LLC, Charlottesville, Virginia, USA.
James F KelleyInspired Therapeutics LLC, Charlottesville, Virginia, USA.

Funding

Development of the Inspired Therapeutics NeoMate Mechanical Circulatory Support System for Neonates and InfantsR44HL144214 · NHLBI · INSPIRED THERAPEUTICS, LLC · PI TAMEZ, DANIEL · 2022 to 2025
$6.1M
NHLBI NIH HHS R44 HL144214NIH HHS 2R44HL144214
6 · The paper itself

Abstract

backgroundInspired 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.

methodsCFD 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).

resultsCFD 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.

conclusionsThe 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.

Indexed as

Heart-Assist DevicesHeart FailureAnimalsAnimals, NewbornComputer SimulationEquipment DesignFeasibility StudiesHemodynamicsHumansHydrodynamicsInfant, NewbornModels, CardiovascularProsthesis DesignSheepcomputational fluid dynamicsheart failureinfantmechanical circulatory supportmock flow loopneonateovine modelpediatric

Identifiers

PMID42049685
PMCPMC13170485

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.