ILUMIEN™ PCI Optimization System The real voyage of discovery consists of not in seeking new landscapes, but in having new eyes. -  Marcel Proust  

il·lu·mi·nate That which illuminates gives light; especially, adjective, noun ,verb (used with object) to supply or brighten with light; light up. (OCT) to make lucid or clear; throw light on (a subject). (FFR+OCT) to enlighten, as with knowledge. (FFR+OCT) That which illuminates gives light; especially, intellectual light or knowledge.

With Knowledge Comes Clarity

Optimize PCI What to treat (FFR) → How to treat (OCT) Knowing which lesion to treat and how to treat it is the key to optimizing interventional treatment strategies.

PCI Optimized by FFR and OCT FFR OCT FFR guides PCI by identifying culprit lesions responsible for ischemia, ensuring a fully functional revascularization. Compared to PCI guided with angiography alone, FFR-guided PCI greatly improves outcomes.1 ↓ PCI Optimized by FFR and OCT FFR ‘WHAT TO TREAT’ IDENTIFY culprit lesions for full functional revascularization OCT ‘HOW TO TREAT’ OPTIMIZE Stent implantation with superior visualization ↑ The ultra high resolution of OCT makes it the ideal tool to visualize vasculature, optimize stent implantation, strut coverage, neointimal response and follow-up.²,³

One Platform. Light Years Ahead. Moving Forward.

Mobile Integration “The ease of use of an integrated system — with the flexibility and cost efficiency of a mobile unit”

Improved Flexibility = Cost Effectiveness Mobile Integration Improved Flexibility = Cost Effectiveness Permanently installed wireless Wi-Box

Mobile Integration Fast Easy Flexible Wireless FFR setup 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 procedures Flexible Integrated case storage and easy patient ID retrieval Software upgradeable

The first system combining FFR and OCT The Clear Advantage FFR: FAME Study1 and Wireless Technology FAME Shows that FFR: Reduces rates of death, myocardial, infarction and repeat revascularization Identifies culprit lesions that can cause ischemia, Is cost saving and does not prolong procedure time. ILUMIEN has Wireless FFR. PressureWire™ Aeris™ OCT: Original and Superior (to any existing imaging) ILUMIEN OCT resolution is 10 times better and 20 times faster than IVUS.4-8 Optimize stents: Implantation, placement, strut coverage, neointimal response and follow-up.2,3 Differentiate and classify plaque.9 The first system combining FFR and OCT

The Clear Advantage First to combine FFR and OCT in one convenient system Wireless (FFR) for easy set-up Quick, easy transition between rooms Sole sponsor of the FAME trial with PressureWire Aeris Provides physicians with more information to optimize PCI

ILUMIEN Video

REFERENCES 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):213-224. 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;3:76-84. Santos MC, Lin T, and Barlis P. In-stent restenosis associated with stent malapposition: Seven year optical coherence tomography findings. Int J Cardiol. (2010), doi:10.1016/j.ijcard.2010.02.068. Nissen SE, Yock P; Intravascular Ultrasound: Novel Pathophysiological Insights and Current Clinical Applications. Circulation 2001;103;604-616. Dijkstra J, Koning G, Reiber JHC; Quantitative Measurements in IVUS Image. International Journal of Cardiac Imaging 15: 513-522, 1999. St. Jude Medical. Data on file. Volcano Corporation, R-100 Instructions for Use. Boston Scientific Corporation, Galaxy Instructions for Use. 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):401-15.  

Rx Only Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Product referenced is approved for CE Mark. ILUMIEN, Mobile Integration, Wi-Box, PressureWire, Aeris, RadiAnalyzer, Dragonfly, C7-XR, Golden Image, the color gold, Radi, LightLab, ST. JUDE MEDICAL, the nine-squares symbol and MORE CONTROL. LESS RISK. are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its related companies. ©2011 St. Jude Medical, Inc. All rights reserved. IPN 1683-11