# New generation of catheters for treatment of atrial fibrillation

> **NIH NIH R44** · LUXMED SYSTEMS, INC. · 2024 · $998,658

## Abstract

ABSTRACT
Atrial fibrillation (AF) remains the most commonly occurring cardiac arrhythmia. It is associated with a lower
quality of life and a higher rate of morbidity and mortality primarily due to poor hemodynamic performance and
often stroke. One of the primary options to treat AF is cardiac ablation where the physician applies radiofrequency
energy via percutaneous catheters to form a series of lesions that directly destroys or isolates abnormal sources
of electrical activity. Specific to AF ablation, a series of lesions are created to encircle the pulmonary veins
forming an electrical barrier that isolates the arrhythmogenic foci inside the vein from the rest of the heart.
However, while attempting to form lesion sets, the physician inadvertently leaves viable gaps that can be
extremely difficult to detect, especially when the tissue is electrically stunned but remains metabolically viable.
When this happens, these gaps will heal over time and reconduct the abnormal electrical activity to the rest of
the heart, causing high post-procedural recurrence rates. As such, there is a strong clinical need to identify these
gaps. Unfortunately, to date there are limited means for real-time monitoring of tissue injury and gap detection
during ablation procedures and there are no means of directly detecting permanently damaged cardiac tissue.
Here we propose to commercialize a new generation of percutaneous catheters that can distinguish viable from
ablated cardiac tissue by sensing, in real time, spectral changes in tissue autofluorescence profiles caused by
thermal damage. During the Phase II we produced and tested in live animals two versions of catheters, one that
acquires an optical signature from a single fiber at the point where catheter tip touches the tissue, and a more
complex version capable of hyperspectral imaging. This Phase IIB proposal seeks NIH funding to help
commercialize the first optically enabled therapeutic ablation catheters under the trade name OmniView™. The
first major task of the proposal to do so will be to manufacture 270 catheters and 20 instruments to be used for
V&V testing and the subsequent clinical trial. These catheters and the instruments will undergo extensive V&V
safety testing based upon standards outlined in the proposal. GLP live animal testing will be conducted in the
large-animal porcine model. Following successful V&V testing, we will prepare an Investigational Device
Exemption document set for submission to the FDA in order to receive permission to begin the clinical trial. We
have identified five hospital sites with highly regarded electrophysiologists who are eager to participate. We have
also held initial meetings with the FDA to obtain feedback on clinical strategy and have identified a CRO for
clinical trial oversight. We will then perform the clinical trial as the key step towards commercialization. In
summary, there remains an unmet clinical need for a system that can distinguish, in real-time, healt...

## Key facts

- **NIH application ID:** 10808934
- **Project number:** 5R44HL120511-05
- **Recipient organization:** LUXMED SYSTEMS, INC.
- **Principal Investigator:** Omar Amirana
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $998,658
- **Award type:** 5
- **Project period:** 2014-07-14 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10808934

## Citation

> US National Institutes of Health, RePORTER application 10808934, New generation of catheters for treatment of atrial fibrillation (5R44HL120511-05). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10808934. Licensed CC0.

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