# Development of an intravascular circulatory support device for high-risk for percutaneous coronary intervention and cardiogenic shock

> **NIH NIH R43** · RT CARDIAC SYSTEMS, INC. · 2020 · $491,583

## Abstract

The objective of this proposal is to continue engineering development and pre-clinical testing of a novel
percutaneous mechanical circulatory support (pMCS) device for use during high risk percutaneous coronary
intervention (PCI) and cardiogenic shock (CS). The high-incidence of PCI and CS are significant and
increasing worldwide, representing a major burden in terms of health care resources and costs. Current
treatment options, including medications and other medical devices, are limited by ineffectiveness, insufficient
support, adverse events, and/or require major surgical intervention. To address this need, RT Cardiac
Systems (RTCS, Cary NC) has developed novel blood pump technology enabling greater hemodynamic
support than previously possible. Other companies report high “peak flows” at sub-therapeutic aortic
pressures indicative of poor patient prognosis and/or severe aortic insufficiency. The RTCS device provides
mean flow over 4 L/min against mean aortic pressure of 80 mmHg, which is sufficient to restore end organ
perfusion. Other known devices can only produce mean flows of 3 L/min or less at this therapeutic condition.
With extensive blood pump design gained developing the HeartWare HVAD, MVAD, and intraventricular
MVAD family of chronic LVAD’s, RTCS has achieved this high level of support with low levels of blood trauma.
Subsequently, RTCS has the expertise, experience, and confidence that we will achieve our objective of
commercializing a competitive pMCS device to improve therapy for high-risk PCI and CS patient populations.
The proprietary RT Cardiac System pMCS device (US patent application 15/676,281) consists of a
miniaturized axial flow pump (2-bladed impeller, 3-bladed diffuser) and an intravascular motor (slotted,
brushless DC motor) connected via a short flexible drive system. The device flexibility improves implantation
and resistance to occlusion as the device adapts to the native left ventricle anatomy. The short drive system
design, including bearing material selections, does not require an external purge of lubrication system that is
required of all other known devices. The high hydraulic efficiency of the pMCS device reduces blood trauma,
required motor torque, and rotational speed to achieve design flow rates. The high motor efficiency reduces
the power required and heat dissipation load. Rigor of prior research with proof-of-concept testing was
demonstrated as evidenced by completion of flow visualization (capacity, washing, blood preservation) and in
vitro (hydraulic and electro-mechanical performance) analyses.
In this phase I project, we will (1) complete fabrication of the pMCS motor system (Aim 1); (2) demonstrate
engineering performance in static (HQ curves) and dynamic (hemodynamics) mock loop model (Aim 1), (3)
demonstrate system reliability in 30-day system reliability testing (Aim 1), (4) demonstrate physiologic efficacy
(hemodynamics, blood, imaging) in a large animal model (Aim 2), and (5) evaluate surgica...

## Key facts

- **NIH application ID:** 10006621
- **Project number:** 1R43HL152774-01
- **Recipient organization:** RT CARDIAC SYSTEMS, INC.
- **Principal Investigator:** Jeffrey LaRose
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $491,583
- **Award type:** 1
- **Project period:** 2020-05-01 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10006621

## Citation

> US National Institutes of Health, RePORTER application 10006621, Development of an intravascular circulatory support device for high-risk for percutaneous coronary intervention and cardiogenic shock (1R43HL152774-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10006621. Licensed CC0.

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