ILUMIEN PCI Optimization System. Illuminating the Future of PCI Optimization. With Knowledge Comes Clarity. Mobile Integration. Product Overview.

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1 Home» Products» All International Products» ILUMIEN PCI Optimization System ILUMIEN PCI Optimization System This device is commercially available for use in select international markets. Illuminating the Future of PCI Optimization The ILUMIEN PCI Optimization System provides the physician unprecedented physiological and anatomical insight to improve diagnostic therapy and optimize PCI. Product Overview With Knowledge Comes Clarity Knowing which lesion to treat and how to treat it is key to optimizing interventional treatment strategies. The ILUMIEN system is the first to combine the functional modality of fractional flow reserve (FFR) and the anatomical modality of optical coherence tomography (OCT) to provide the physician insight to help diagnose and treat coronary artery disease and optimize percutaneous coronary intervention (PCI). Mobile Integration The ease of use of an integrated system with the flexibility and cost efficiency of a mobile unit. Fast Wireless FFR set-up in one or multiple labs Move between FFR and OCT modalities with one touch Easy Quick and easy movement between multiple labs Easy on-screen guide simplifies ILUMIEN FFR and OCT procedures with a new, seamless user interface Flexible Integrated case storage and easy patient ID retrieval Accommodates future updates and technology Technical

2 ILUMIEN PCI Optimization System Size (mm) Maximum Frame Rate (fps) Nominal Pullback Speed Lines per Frame Scan Diameter (mm) Axial Resolution (µm) 1430 (h) x 471 (w) x 683 (d) mm/sec Contents (1 unit per box) OCT Imaging Engine Application Software Package Drive-motor and Optical Controller ILUMIEN Custom Computer Operator's Monitor High Resolution LCD17" Physician's Monitor High Resolution LCD 19" Integrated Mobile Console Keyboard and Mouse Accessory Tools Operator's Manual ILUMIEN PCI Optimization System C7 Dragonfly Intravascular Imaging Catheter Usable Length (cm) Intracoronary Usable Length (cm) Outer Diameter (distal) Wire Lumen (in) Coating F Hydrophilic Kit Contents (1 unit per box) C7 Dragonfly Intravascular Imaging Catheter Sterile DOC cover Sterile 3 ml syringe KT C7 Dragonfly Imaging Catheter PressureWire Aeris

3 Pressure Pressure Range Pressure Accuracy Frequency Response -30 to +300 mmhg ±1 mmhg plus ±1% of reading (over the pressure range - 30 mmhg to 50 mmhg) ± 3% of reading (over the range 50 mmhg to 300 mmhg) DC to 25 Hz Wireless Transmission Radio Range Battery Time Transmitter Frequency Range Radio Type Radio Power Total Signal Time Delay 2 m (15 20 m in free line of 3 hours GHz (ISM band) Frequency hopping spread spectrum 1 mw peak, 70 µw average <10 ms sight) (FHSS) PressureWire Aeris, 175 cm Wi-Box Power Input External Power Supply Input Transducer Impedance Accuracy 2.4 to 8 VDC (for 2.4 to 4 VDC, use Wi-Box External Power Supply) 100 to 240 VAC, Hz > 270 Ω ±1 mmhg or ±1% of reading, whichever greatest Resolution Bandwidth Weight Dimensions 0.2 mmhg 0-50 Hz 0-25 Hz 108 x 87 x 33 mm Radio Frequency Range Type Range External Power Supply AO IN, AO OUT GHz Frequency-hopping spread 0 4 m Electrical safety Galvanically (ISM-band) spectrum (FHSS) Class II connected CF, Defibrillation Proof C12783 Wi-Box Cables (for initial installation) are available separately. Please refer to your St. Jude Medical product catalog. NOTE: One Wi-Box is needed for each cath lab where ILUMIEN is used. How it Works FFR Physiological Assessment Know What to Treat FFR allows more accurate identification of hemodynamically significant stenoses, reducing rates of death, myocardial infarction and repeat revascularization 1.

4 FFR-guided PCI significantly reduces mortality and results in reduced procedural and healthcare costs, without prolonging the cath lab procedure compared to angiography alone 1 Recognize lesions that can cause ischemia Determine if blood flow is sufficiently restored after balloon or stent deployment In addition, Wi-Box provides a wireless connection to ILUMIEN, and is permanently installed between the AO-transducer and hemodynamic recording system. FFR is always available - all labs - anytime. OCT Anatomical Assessment Know How to Treat The ILUMIEN system incorporates the most advanced OCT technology for enhanced anatomical assessment and PCI optimization. Optimize stent implantation, strut coverage, neointimal response and follow-up 2-3 Evaluate stent placement, expansion and apposition Differentiate and classify plaque 4 Evaluate lumen area quickly, with accurate automated measurements The ILUMIEN system has 10 times better resolution and is 20 times faster than IVUS (acquires full vessel segment pull-back in under 5 seconds) 5-9. Image Samples Malapposed stent struts with early tissue coverage Two edge dissections Circumferential calcium White thrombus at side branch The familiar gold color and Golden Image of OCT are available exclusively with the St. Jude Medical ILUMIEN and C7-XR systems. References Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. FAME study. N Engl J Med. 2009;360(3): Murata A, Wallace-Bradley D, Tellez A, et al. Accuracy of optical coherence tomography in the evaluation of neointimal coverage after stent implantation. JACC Cardiovasc Imaging. 2010;3(1): Santos MC, Lin T, Barlis P. In-stent restenosis associated with stent malapposition: Seven year optical coherence tomography findings. Int J Cardiol. 2011;147(1): Prati F, Regar E, Mintz GS, et al. Expert review document on methodology, terminology, and clinical applications of optical coherence tomography: Physical principles, methodology of image acquisition, and clinical application for assessment of coronary arteries and atherosclerosis. Eur Heart J. 2010;31(4): Nissen SE, Yock P. Intravascular unlrasound: Novel pathophysiological insights and current clinical applications. Circulation. 2001;103(4);

5 Dijkstra J, Koning G, Reiber JH. Quantitative measurements in IVUS images. Int J Card Imaging. 1999;15(6): St. Jude Medical. Data on File. Volcano Corporation, R-100 Instructions for Use. Boston Scientific Corporation, Galaxy Instructions for Use. Clinical Data FAME STUDY 1 One-year Outcomes The PressureWire sensor was the exclusive FFR technology used in the FAME Study. Compared to angiography only procedures, the FAME one-year study results showed that FFR: Reduces composite rates of death, myocardial infarction, re-pci, and CABG at one year by 28% Reduces mortality and myocardial infarction at one year by 34% Is cost-saving and does not prolong procedure time Decreases amount of contrast agent used Results in similar, if not better, functional status Recently Upgraded to the Highest Level of Evidence by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery, (EACTS)2 FFR was upgraded to the highest level of evidence, (Class I, Level of Evidence A) by the ESC and EACTS. This upgrade was driven by the positive results of the landmark FAME study. The current guidelines recommend measuring FFR before deciding on PCI or surgery. References 1. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3): European (ESC/EACTS) guidelines 2010: Wijns, et al., Eur Heart J. 2010; first published online August 29, View Indications, Contraindications, Warnings, Precautions & Potential Adverse Events Related Topics of Interest Products (3) Request More Information Complete the form below to have a St. Jude Medical sales representative contact you. * Indicates a required field.