POWERFUL VISION TO TRANSFORM YOUR PRACTICE

DCR15-073MK0285

Established in 1999 by cardiologist Dr. James Muller, Infraredx is driven to transform global standards of cardiovascular medicine. Harnessing 30 years of research into the association between heart attacks and lipid core plaque, Infraredx has been committed since its founding to the design, manufacture, and distribution of technologies that address the needs of practitioners and improve outcomes in the treatment of patients with coronary artery disease.

Infraredx has developed the dual modality Advanced TVC Imaging System™, the first and only FDA approved advanced imaging system that provides today’s clinical practitioner with a compre-hensive map of vessel structure and plaque composition. With investment in several landmark global clinical trials, Infraredx’s mission is to enable interventional cardiologists to predict heart attacks and prevent them.

Infraredx 34 Third Avenue Burlington, MA 01803

888-680-REDX (7339) +1-781-221-0053

www.infraredx.com

Advanced TVC Imaging System™ & Muller Catheter™

IMAGE ACQUISITION MODES Live IVUS (Manual) or Automated Pullback

HARD DRIVE CAPACITY 500 GB (approximately 1000 scans)

DATA ARCHIVING FORMATS DICOM, AVI, PDF, JPEG, TVC native format

DATA EXPORT METHODS PACS, USB, DVD, Bluetooth Printing

OPERATING FREQUENCY BANDWIDTH 30-70 MHz

MINIMUM GUIDE CATHETER 6 Fr (1.70 mm Inner Diameter)

MAXIMUM GUIDE WIRE 0.014" (0.36 mm)

DELIVERY PLATFORM TYPE Monorail (25 mm)

SHAFT PROFILE 3.6 Fr (1.2 mm)

CROSSING PROFILE 3.2 Fr (1.1 mm)

TIP ENTRY PROFILE 2.4 Fr (0.8 mm)

WORKING LENGTH 160 cm

DUAL-LAYER HYDROPHILIC COATING LENGTH 50 cm

PULLBACK/IMAGING LENGTH 120 mm

©2015 Infraredx, Inc.

CLARITY. DEPTH. CERTAINTY. THE NEW EXTENDED BANDWIDTH DIFFERENCEWith standard intravascular ultrasound (IVUS), practitioners currently make a trade-off between image clarity and signal penetration. These compromises can make a difference when trying to accurately assess a vessel and interpret the image for optimal treatment. There’s only one choice when it comes to a single, uncompromised image: the Advanced TVC Imaging System™.

• Proprietary Extended Bandwidth technology harmonizes multiple signal frequencies. The result is a sharp image of the complete vessel that allows for easy identification of the lumen, plaque and vessel structure.

• The Extended Bandwidth transducer detects the size, shape, and borders of vessels and plaques in fine detail and high contrast, coregistered with near-infrared spectroscopy (NIRS) compositional data.

• The Extended Bandwidth composite display provides a clear, easy-to-interpret map for identifying high-risk patients with high-risk plaques.

Composite IVUS Image

Extended Bandwidth IVUS™ vs. Top Competitors

FUNCTIONAL SIGNAL STRENGTH

Typical 20 MHzInfraredx®

Extended Bandwidth IVUS™

Higher frequencies (up to 70 MHz) =+ Image clarity

+ Crisp detail for fine structures

- Low signal penetration

Lower frequencies (down to 30 MHz) =+ Image depth-of-field

+ Dark lumen

- Low overall resolution

- Lacking fine detail

LOWER FREQUENCY INCREASES DEPTH-OF-FIELD HIGHER FREQUENCY IMPROVES CLARITY

Typical 40 MHz

Flexible workflow keeps you in sync with the procedure

Clear command screen offers easy access to area measurement and image review tools

Thumbnail images simplify interpretation of lesions

Streamlined, low profile design

Top-of-line, 21.5" HD antiglare monitor

Industry-first Bluetooth wireless case printing

Large, movable physician monitor provides excellent visibility for clear, timely decision-making

ADVANCING THE FUTURE OF INTERVENTIONAL MEDICINEInfraredx’s mission is to empower interventional cardiologists with the advanced imaging tools required to predict heart attacks and prevent them—catalyzing a global shift from reactive treatment to proactive care of coronary artery disease. With the introduction of our next generation Advanced TVC Imaging System™, we offer not just a vision for the future of the field, but a practical and easy-to-use technology essential for today’s leading catheterization labs.

• The Advanced TVC Imaging System is the only FDA indicated imaging system that can detect lipid core plaques (LCP), which are associated with 95% of STEMIs, and an increased risk of periprocedural adverse events.1, 2

• Novel laser-optic near-infrared spectroscopy (NIRS) safely characterizes plaque composition and automatically calculates lipid burden.

• Coregistered NIRS-IVUS provides structural information in real-time with a composite map of the vessel.

• The Advanced TVC Imaging System powers confident decision-making, today and tomorrow.

Expert Made Easy with the Chemogram Map of High Risk Plaques

CHEMOGRAM LEGEND

Low Probability of LCP

High Probability of LCP

NIRS data for an entire vessel is displayed in the chemogram, an easy to understand map of an artery. Simple color-coding means lipid core plaques can be found and assessed at a glance.3 The lipid core burden index (LCBI) also provides a simple numeric indicator of lipid content.

1 Detection by NIRS of LCPs at Culprit Sites in Patients with Acute STEMI, Madder et al, JACC Interv, 2013

2 Detection of LCPs by Intracoronary NIRS Identifies High Risk of Periprocedural MI, Goldstein et al, Circ, 2011

3 Detection of LCPs in Autopsy Specimens With a Novel Catheter-Based NIRS System, Gardner et al, JACC Imaging, 2008

Only Infraredx can provide True Vessel Characterization (TVC)—the accurate, reliable, rapid and simultaneous assessment of both composition and structure.

0°

360°

PROXIMAL DISTAL

Lipid Core Plaque

CHEMOGRAM

Fibrotic Tissue

ADVANCED FEATURES, ADVANCING OUTCOMESDesigned with feedback from leading interventional cardiologists, the Advanced TVC Imaging System™ brings together powerful advanced imaging capabilities in a user-friendly solution—for seamless integration within the cath lab to support daily caseloads and drive improved long-term patient outcomes.

Clinical Benefits:Discover Culprit Lesions:

• See real-time information about vessel structure including plaque burden and composition

• Assess lesion size, shape, and structure to manage patient risk

Optimize Procedures:

• Define normal-to-normal to plan local treatment areas and stent landing zones

• Determine stent diameter and length for complete lesion coverage

• Personalize medical therapy plans

Monitor Outcomes:

• Confirm stent expansion and apposition

• Evaluate a patient’s disease profile over time

Improving Patient Outcomes

1 Meta-Analysis Of Outcomes After IVUS-Guided Versus Angiography-Guided DES Implantation in 26,503 Patients Enrolled in Three Randomized Trials And 14 Observational Studies, Ahn et al, Am J Cardio, 2014

2 Relationship Between IVUS Guidance And Clinical Outcomes After DES: The Assessment Of Dual Antiplatelet Therapy With DES, Witzenbichler et al, Circ, 2013

3 Witzenbichler - ADAPT -DES Study; PowerPoint presentation to TCT 2013: Oct. 27 – Nov. 1, 2013, San Francisco, CA

4 Impact Of IVUS Imaging on Early and Late Clinical Outcomes Following PCI with DES, Claessen et al, JACC Interv, 2011

Myocardial Infarction 1, 3, 4

ANGIO ONLY TVC-GUIDED ANGIO ONLY TVC-GUIDED

Stent Thrombosis 1, 2, 3

>33% reduction in ST>42% reduction in MI

TVC Muller Extended Bandwidth NIRS-IVUS Catheter™