ILUMIEN™ PCI Optimization System

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

ILUMIEN™ PCI Optimization System

Specifications

 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

Order Information

C7 Dragonfly™ Intravascular Imaging Catheter

Specifications

Kit Contents (1 unit per box)

• C7 Dragonfly Intravascular Imaging Catheter
• Sterile DOC cover
• Sterile 3 ml syringe

Order Information

PressureWire™ Aeris™

Pressure Specifications

Wireless Transmission Specifications

Order Information

Wi-Box™

Specifications

Resolution	Bandwidth	Weight	Dimensions
≤ 0.2 mmHg	0-50 Hz	0-25 Hz	108 x 87 x 33 mm

Radio Specifications

Order Information

 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.

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.

• FFR-guided PCI significantly reduces mortality and results in reduced procedural and healthcare costs, without prolonging the cath lab procedure compared to angiography alone¹
• 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 plaque⁴
• 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

1. 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):213-24.
2. 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):76-84.
3. 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):149-51.
4. 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. 
5. Nissen SE, Yock P. Intravascular unlrasound: Novel pathophysiological insights and current clinical applications. Circulation. 2001;103(4);604-16.
6. Dijkstra J, Koning G, Reiber JH. Quantitative measurements in IVUS images. Int J Card Imaging. 1999;15(6):513-22.
7. St. Jude Medical. Data on File.
8. Volcano Corporation, R-100 Instructions for Use.
9. Boston Scientific Corporation, Galaxy Instructions for Use.

FAME STUDY¹

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):213-224.
2. European (ESC/EACTS) guidelines 2010: Wijns, et al., Eur Heart J. 2010; first published online August 29, 2010.