Intravascular/ Diagnostics Imaging FFR OCT INTRAVASULAR ULTRASOUND INFRAREDX TVC IVUS VH IMAGING Dr. Waksman IVUS OPTICAL COHERENCE TOMOGRAPHY BY DONALD HARRINGTON

Donald L. Harrington, RCIS I/we have no real or apparent conflicts of interest to report.

Objective: To share an overview of the imaging technologies used in the Washington Hospital Center’s Cath. Lab.

TOOLS OF THE TRADE FOR Intravascular/ Diagnostics Imaging In THE WHC CATH. LAB Knowing which lesion or lesions to treat and how to treat these diseased areas is the key for best PCI treatment strategies. All of our systems are the first to combine the function of: Fractional Flow Reserve (FFR) Optical Coherence Tomography (OCT) Intravascular Ultrasound (IVUS)/ VH LipiScan/ IVUS To provide the physician with the best insight to help diagnose and treat coronary artery disease FFR- TWO SYSTEMS ST. JUDE VOLCANO OCT- ONE SYSTEM IVUS- THREE SYSTEMS BSC INFRAREDX VH - ONE SYSTEMS LipiScan/ IVUS –ONE SYSTEM

The Benefits of Our Tools Our mobile units are easy to move The ease of use of integrated systems in our Cath. Lab rooms Flexibility and cost effectiveness for staff and procedures Fast and easy - Wireless FFR, FFR, IVUS and OCT set-up in one or multiple labs Move between FFR and OCT modalities with one touch Easy on-screen guide simplifies ILUMIEN FFR or FFR and OCT or IVUS procedures with a new user interface touch Flexible and quick set-up Integrated case storage and easy patient ID retrieval info Accommodates future updates and technologies to come Quick and accurate information of the lesion study to be analyzed for intervention

ILUMIEN PCI Optimization System The system provide high resolution imaging to show: Plaque rupture Intracoronary thrombus Fibrous caps, calcium, dissection, etc. Stent apposition and malappostion Tissue protrusion after stenting Neointimal hyperplasia All done with OCT with the side arm of wireless FFR (FAME STUDY) on the system

ILUMIEN INSIGHT FOR WORK FFR Determine if blood flow is sufficiently before and after PCI FFR allows accurate data of hemodynamically significant stenoses FFR-guided PCI reduces mortality, procedural time, healthcare costs in the cath lab Wi-Box provides a wireless connection to ILUMIEN, and is permanently installed between AO-transducer and hemodynamic recording system FFR is always available in all labs anytime. OCT The ILUMIEN system uses the OCT technology for enhanced lesion assessment and PCI optimization Optimize stent implantation , strut coverage, expansion and apposition Differentiate and classify plaque Evaluate lumen area quickly, with accurate and automated measurements The system has 10 times better resolution and is 20 times faster than IVUS pullback rate (pullbacks in under 5 seconds)

ILUMIEN™ PCI Optimization System First to combine fractional flow reserve (FFR) and optical coherence tomography (OCT) technologies in one unit ILUMIEN represents a giant step forward in optimizing percutaneous coronary intervention (PCI)/research Offers the physician the ability to identify culprit lesion or lesions and clarify treatment strategies

ILUMIEN Mobile Integration For FFR ILUMIEN Offers : Fast and Easy Wireless, FFR set up in one or multiple labs Move between FFR and OCT modalities with one touch The ease of use of an integrated system with the flexibility and cost effectiveness of a mobile unit Quick and easy movement between multiple labs Easy on-screen guide simplifies ILUMIEN FFR and OCT procedures with a new, seamless user interface Flexible Easy patient ID information retrieval for review Accommodates future updates and technology for the future

ILUMIEM SYSTEM

Make Every Call With Confidence IVUS documents your decisions at every stage and is clinically relevant — choose IVUS. Pre-therapy Understanding • Determining lesion significance • Morphological assessment • Interventional sizing Stent Optimization • Stent apposition • Stent expansion • Geographic miss • Edge dissection Clinical Outcomes • TLR and TVF • Death and MI • Thrombosis PC BASE SYSTEMS STATE OF THE ART DESIGN UPGRADABLE EASY TO USE LIGHTWEIGHT CARTS SUPER FEATURES SAVE TO ALL MEDIA AND REVIEW SMALL UNITS PLUG & PLAY

Install IVUS Imaging Systems Support MHz IVUS catheters and FFR pressure wires Chroma-Flo technology for the blood flow Measurements – vessel/lumen diameter, surface area and percentage User friendly, PC base Lightweight, maneuverable, easy to use All S5i™, IVUS is always ready and always on and plug/play No need to install transport a console from lab to lab Install IVUS Imaging Systems Volcano s5 Imaging System

Volcano s5 Imaging SystemS

INFRAREDX TVC Imaging system Intravascular imaging system has the ability to assess vessel composition and structure using integrated NIRS (near infrared spectroscopy) lipid core plaque detection and enhanced IVUS The TVC Imaging System enables identification and location of vessel's LCP or LCB (lipid core plaques or burden) The TVC IVUS Imaging System provides information about vessel structure, including lumen dimensions, degree of stenosis, and plaque burden, etc. The TVC Imaging System is the first and only FDA-cleared device for the detection of lipid core plaques (LCP) The CANARY clinical study is a randomized pilot trial of the use of a distal protection device to prevent peri-procedural MI during dilation of coronary stenoses caused by plaques with large lipid cores

INFRAREDX TVC Imaging system TVC or True vessel characterization is the accurate, reliable, and rapid assessment of vessel composition and structure for treatment strategies. True vessel characterization may have value in: Improved stentting therapy and treatment strategies of coronary artery disease Detailed risk stratification of CAD Adjustment of pharmaceutical therapy

InfraReDx LipiScan IVUS Coronary Imaging System TVC/Pre LAD: LCBI 113 TVC RCA: LCBI 0

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Determining Lesion Significance IVUS can help Identify large plaque burden and can help assess whether the lesion is flow-limiting. “IVUS and FFR can both be used to assess intermediate lesions. IVUS helps me facilitate optimal stent expansion and apposition.” Michael Lee, MD Ronald Reagan UCLA Medical Center

SHOWCASE THE GOLD STANDARDS OF IVUS AT WHC

ILab Ultrasound Imaging System Convenient to Use Installed system reduces set up time Control the case from imaging to measurement from the sterile field Enhanced Clinical Value Provides full cross-section IVUS images alone or in combination with measurement of lesion length on a LongView™ Image Automatically determines vessel and lumen borders, which gives plaque burden and percent area stenosis measurement for clinical decision making Additional Software Features Trace Assist : Automatic detection lumen and vessel borders Dynamic Review : Animates IVUS images for image interpretation Archives complete cases: on CD, DVD, removable hard drive or DICOM network iReview : Offline DICOM viewing software allows for post-procedure case viewing Continuous Upgradable: software development efforts to improve the clinical value of the IVUS image. Intuitive Hardware Installed Systems and multiple monitor-mounting into the cath lab procedure rooms Tableside Controller: Provides sterile field control of IVUS measurement and playback of IVUS runs Touch Panel: Intuitive user interface and simplified display iLab 1.3 – 2.7 System Software iSize : preview device sizing decisions by displaying area and length measurement graphics* iColor: Enhances image interpretation by adding color to the cross-sectional IVUS view, coloring plaque and lumen based on Trace Assist™ iTint: Provides uniform tint to IVUS screen with color ( red, blue, yellow or green) Icon Magnifier: Zoom feature that enlarges icons on the main IVUS screen New Run Icon: to start a new run from the main screen

Install IVUS Imaging Systems

Conclusion All of the diagnostic tools used in the Washington Hospital Center’s Cath. Lab are state of the art technologies. Each tool is designed to make our job easier, and to provide the information necessary to help patients have the best outcome possible.

THANK YOU! DLH