Study in The Lancet successfully demonstrated endpoints of identifying both vulnerable patients & plaques at a significantly higher risk for subsequent MACE. View now View Now

Background & Definition

Despite optimal medical therapy and risk modification strategies, coronary events continue to occur. Many individuals with an adverse risk factor profile remain asymptomatic. The quest for detecting patients at risk for a secondary cardiovascular event (cardiac death, and MI) is a high priority. Lipid Rich Plaques (LRP) have been shown to be associated with ACS & MI and can be detected by Near Infrared Spectroscopy (NIRS) imaging.

Near Infrared Spectroscopy (NIRS)

WHY

NIRS Spectroscopy?

To identify lipids such as cholesterol

Organic molecules have unique spectroscopic signatures that can be used to detect their presence in a mixture of unknown composition. NIRS allows us to distinguish molecules, such as collagen and cholesterol, within the vessel wall and thus identify the presence of LCP.

WHERE

does the Light Propagate?

Through blood, tissue and interstitial spaces

The microscopic mirrors at the tip of the Dualpro™ catheter are designed to deliver near-infrared light to the vessel wall and collect the diffusely reflected light. The light propagates through blood and tissue by scattering and absorption, even in the presence of calcium or stents, to interrogate the plaque for its chemical fingerprint.

HOW

are the Spectra Interpreted?

With the aid of advanced algorithms

Advanced algorithms analyze the returned light and calculate the probability of the presence of a lipid core plaque. Our algorithms have been validated in a large prospective histology study providing you with information you can trust.

Histology Validated

Nearly 2,500 artery cross-sections were histologically and spectrally analyzed to validate lipid core plaque detection by NIRS. The red and yellow colors on the chemogram help differentiate normal or fibrotic plaque that is presumed to be stable from those that contain lipid core plaques.

Lipid Core Burden Index (LCBI)

The Lipid Core Burden Index (LCBI) is validated as quantitative summary metric of the Lipid Core in a scanned or selected region. The chemogram and LCBI are generated by the system automatically.

LCBI scale is from 0 to 1000

LCBI = (Yellow pixels x 1000) / (Total valid pixels)

maxLCBI4mm: The maximum 4mm LCBI value in a scanned or selected region

Previous Studies

Prior Studies: NIRS Predicts Patient-Level NC-MACE

203 patients, 1 year follow up
HR = 4.04
Oemrawsingh RM, et al.
J Am Coll Cardiol. 2014
121 patients, 2 year follow up
HR = 10.2
Madder RD, et al. Eur Heart
J Cardiovasc Imaging. 2016
275 patients, 4 year follow up
HR = 3.22
Schuurman AS, et al.
Eur Heart J. 2017
239 patients, 5 year follow up
HR = 14.05
Danek BA, et al. Cardiovasc
Revascularization Med. 2017

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