# Real-time, High Resolution Ultrasound-based Image Guidance System for Pericardial Access

> **NIH NIH R43** · PERCEPTIVE NAVIGATION, LLC · 2021 · $261,094

## Abstract

The cardiac electrophysiology ablation market is projected to exceed $6.5 billion by 2026 at a compound
annual growth rate of 13.1% of which epicardial ablation is estimated as an $800 million market. Epicardial
ablation that requires entry into the pericardial space is increasingly being used to address resistant cardiac
arrhythmias. However, currently, access to the pericardial space remains a technical challenge because 1) a
trial and error technique is used; 2) it is x-ray/fluoroscopy based so it entails x-ray radiation and toxic
angiographic dye; 3) x-ray cannot differentiate between soft tissues so the operator is not able to visualize the
pericardial border or differentiate between the pericardium and the heart, and 4) because it is somewhat blind,
there is increased risk and it is time consuming. Perceptive Navigation has developed a forward-viewing,
ultrasound-based, image-guidance platform that enables safe, reliable and accurate skin-to-target access. This
Phase I SBIR submission seeks to build on that platform to facilitate access to the pericardial space to enable
epicardial electrophysiology applications. Significant progress has been already achieved in building a working
prototype of our ultrasound (US)-based image guidance platform. We have already (a) fabricated and
characterized a forward-viewing phased array transducer for vascular and heart access, (b) successfully
performed vascular access in live experimental models, (c) completed biocompatibility (cyto and systemic
toxicity, chemo-irritation/ sensitization) testing of the vascular access catheter. Our overall phase I goals are to
customize this platform via iterative design and fabricate a clinical-grade prototype of a pericardial access
device. In phase I we propose fabricating and integrated, multicomponent device configured such that an
advancing needle is continuously visualized in real-time. Portions of the device have already been developed
and validated for vascular access. In pilot studies, an early prototype of proposed system provided real-time
vision of the advancing needle and pericardium enabling complication-free pericardial entry in live domestic
swine with pericardial effusions. We propose the following aims: Aim 1: Iteratively design and fabricate a
clinical-grade device. Test feasibility and efficacy of this device for pericardial access in water-bath and tissue
phantoms. Aim 2: Demonstrate functionality and efficacy of the device in explanted swine hearts and in live
swine by testing for ease and success of pericardial entry. Selected designs will be optimized for additional in-
vivo studies and first-in-human clinical trials in a future application. Our long-term goal is to commercialize a
real-time, image-guided pericardial access system that is a novel means of enabling epicardial ablation
procedures. The system would have low capital and operating cost, low profile (hand-carried) and potentially
promote safe and reliable epicardial ablations with red...

## Key facts

- **NIH application ID:** 10139576
- **Project number:** 1R43HL156374-01
- **Recipient organization:** PERCEPTIVE NAVIGATION, LLC
- **Principal Investigator:** RANDALL J. LEE
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $261,094
- **Award type:** 1
- **Project period:** 2021-07-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10139576

## Citation

> US National Institutes of Health, RePORTER application 10139576, Real-time, High Resolution Ultrasound-based Image Guidance System for Pericardial Access (1R43HL156374-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10139576. Licensed CC0.

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