Taking the Guesswork Out of IVUS

www.infraredx.com© InfraReDx, Inc. All rights reserved. Federal law (U.S.A.) restricts this device to use by or on the order of a physician.

Novel Multimodality Intravascular Imaging System Offering Enhanced IVUS to Assess Lesion Structure and Plaque Composition• The LipiScan IVUS system is the world’s only intravascular

imaging system that combines co-registered grayscale intravascular ultrasound (IVUS) together with InfraReDx’s proprietary near infrared (NIR) lipid core plaque (LCP) detection technology.

• LipiScan IVUS uses both light and sound to visualize and characterize coronary lesions. The results provide far more information about coronary plaques and their composition than is provided by angiography.

• The LipiScan IVUS system delivers outstanding visualization of coronary structure and plaque morphology together with a detailed chemical map of the vessel for the simultaneous detection and localization of the LCPs believed to cause heart attacks and complicate stenting procedures.

Key FeaturesThe LipiScan IVUS Coronary Imaging System delivers all the benefi ts of IVUS plus the lipid core plaque detection power of NIR spectroscopy to help physicians optimize their stenting strategy.

• High-fi delity 40 MHz rotational IVUS imaging system utilizes the familiar set-up and workfl ow of conventional IVUS systems.

• IVUS images and NIR spectroscopy Chemograms are obtained simultaneously and are available immediately upon conclusion of the imaging pullback procedure.

• Leading-edge system architecture creates a powerful yet intuitive user interface that delivers vastly more information than conventional IVUS systems.

• Dual 19-inch LCD touch screen monitors offer optimal viewing angles for both physician and operator in all lighting conditions.

How It Works: Enhanced IVUS for Structure and Composition

IVUS is a well established imaging technology used to determine the degree of stenosis caused by coronary artery plaques. It is also used to determine the need for stent placement, and to determine if a stent that is deployed is fully expanded. IVUS, however, is not an optimal method to identify lipid core plaques.

Near-infrared (NIR) spectroscopy is a highly developed analytic technique commonly used to identify the chemical composition of unknown substances. It is based on the differential absorption of light at different wavelengths by different chemicals.

LipiScan™ technology performs NIR spectroscopy inside the coronary arteries to provide an automated, detailed image of the presence and location of lipid core plaque. These image maps, called “Chemograms™”, provide valuable information to interventional cardiologists during the cardiac catheterization procedure.

The LipiScan IVUS system is a novel and unique combination of the complementary technologies of IVUS and NIR spectroscopy. In a single pullback, the physician obtains accurate, co-registered information about plaque structure (from IVUS) and composition (from NIR spectroscopy). This combined information helps cardiologists with decisions regarding the need for a stent, the likelihood that stenting complications might occur, and the results of stent placement.

Taking the Guesswork Out of IVUS

Now FDA cleared for sale in the U.S.

Contact Us for More Information

Address:InfraReDx34 Third AvenueBurlington, MA 01803

Sales:1-888-NIR-IVUS (PHN) (1-888-647-4887)sales@infraredx.com

Customer Service:800-596-3104 (PHN)

781-345-9573 (FAX)

customerservice@infraredx.com

InfraReDx and the InfraReDx Logo are registered trademarks of InfraReDx, Inc.

System Processing & Data StorageOperating SystemWindows XP Embedded

ProcessorIntel Celeron D / Pentium 4

Memory4 GB RAM

Hard Drive Capacity500 GB Internal (OS), 500 GB External (User)

Digital Archiving OptionsLocal hard disk: 250+ CasesDVD – 4.7 GB, AVI, binary data files, PDFsDICOM Network

DICOM Services SupportedDICOM Worklist ManagementDICOM Store

System Power Requirements100 – 120 V~ 50/60 Hz 5A 220 – 240V~ 50/60 Hz 3A

System SpecificationsConsoleDimensions: 26" X 26" X 62" (66 cm X 66 cm X 158 cm) (mast extended)Weight: 300 lbs (136 kg)

Pullback and Rotation Device (PBR)Dimensions: 14.5 X 5.5" X 5" (36.8 cm X 14 cm X 13 cm)Weight: 6 lbs (2.7 kg)

MonitorsDimensions: 15.57" X 18.30" X 3.86" (39.5 cm X 46.5 cm X 9.8 cm)Weight: 14 lbs (3.85 kg)

Key Features• First and only catheter to deliver grayscale IVUS with co-registered NIR spectroscopy for structure

and composition

• High fidelity 40MHz rotational design delivers clear, crisp IVUS image

• Fast and accurate LipiScan™ technology provides for immediate lipid core plaque detection

• Low profile 3.2 French image transmission window and 28mm monorail lumen enhance track and cross

Catheter Technical Specifications Minimum guide catheter 6 French (2mm)Maximum guide wire 0.014" (0.36mm)Catheter Crossing Profile 3.2 French (1.07mm)Maximum Imaging Diameter 16 mmCatheter Working Length 160 cmOperating Frequency 40MHz

Item Catalog Order #LipiScan IVUS Console NIRS-MC7LipiScan IVUS Catheter NIRC-MC7-70-3.2FLipiScan IVUS Sterile Accessory Kit NIRS-MC7-SA

InfraReDx, Inc. is a privately funded medical device company dedicated to improving patient care through development and commercialization of intelligent imaging technologies to advance the diagnosis and treatment of coronary artery disease. Since its founding, InfraReDx has been devoted to overcoming the challenges of performing NIR spectroscopy in the human coronary artery and designed the LipiScan IVUS to better characterize plaques that complicate stenting and cause the majority of heart attacks.

IVUS and Chemogram™ images from a single pullback of the LipiScan™ IVUS Coronary Imaging System.

Co-registered IVUS/NIR Image

Chemogram™

Longitudinal View

LipiScan™ IVUS Coronary Imaging System Specifications

LipiScan IVUS Catheter Specifications

LipiScan IVUS System Ordering Information About InfraReDx, Inc.