FFR and PressureWire ™ Certus

1. FFR and PressureWire™ Certus Rx Only. Caution: Before using PressureWire Certus read the instructions for use which accompany the product for indications, contraindications, warnings and precautions.

2. Fractional Flow Reserve (FFR) Definition of FFR: “Maximum achievable blood flow in stenotic coronary artery divided by Maximum blood flow in the same artery without stenosis”

3. FFR Measurement Correlates to the Likelihood of Ischemia Fractional Flow Reserve (FFR) is a lesion specific, physiological index determining the hemodynamic severity of intracoronary lesions. FFR accurately identifies lesions responsible for ischemia which in many cases would have been undetected or not correctly assessed by angiography or IVUS. FFR Measurement Correlates to the Likelihood of Ischemia with a validated cut off value of 0.75.

4. The FAME Study The FAME (Fractional Flow Reserve vs. Angiography for Multivessel Evaluation)Study one-year results, published in The New England Journal of Medicine, shows that routine measurement of FFR in patients with complex coronary artery disease reduces MACE and makes stent placement more efficient and more cost-effective. In the FAME Study, 1005 patients with multivessel CAD were randomly assigned to FFR-guided PCI or angiography-guided PCI with DES and followed for one year.

5. FAME Study Design Chart Patient with lesions ≥ 50% in at least 2 of the 3 major epicardial vessels Indicate all lesions ≥ 50% amenable for stenting Randomization FFR-guided PCI Angiography-guided PCI Measure FFR in all arteries with ≥ 1 stenosis Stent only those stenoses with FFR ≤ 0.80 Stent all indicated stenoses 1-year follow-up Exclusion criteria: LM disease, Previous CABG MI < 5 days, unless Cardiogenic shock Pregnancy, Life expectancy < 2 years

6. Compared to angiography-only procedures, FAME one-year results show that FFR: Reduces MACE 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. FAME two-year results show that FFR: Reduces mortality and myocardial infarction (combined) by 34%. Reduces myocardial infarction alone by 37%. Is cost saving and improves procedure outcomes. Save on average $2066 over one year. The FAME Study Results

7. PressureWire™Certus The 7th Generation PressureWire

8. PressureWire Certus Generation 7 Engineered for Exceptional Precision, Control and Reliability. Best In Class Handling Precise maneuverability to reach tortuous distal vessels and sharp angled side branches. Versatility The only pressure guidewire on the market offering measurement of pressure and Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR), and Index of Microcirculatory Resistance (IMR). Reliability Unique design reduces risk for signal disturbances during long procedures and extensive handling in the cath lab environment.

9. PressureWire Certus Generation 7 Designed for best in class handling Designed to deliver: • Precise, atraumatic maneuvering and effortless access in challenging anatomy • Smooth interaction with interventional devices

10. New for Generation 7 Continuous taper core wire design Multi-function sensor: FFR, CFR, IMR Hydrophilic coating Hydrophobic connector Polymer sleeve PTFE coating New for Generation 7 Optimized sensor-to-wire transition Large entry funnel New for Generation 7 Packaging tray PressureWireCertus - Overview

11. PressureWire Certus Generation 7 Continuous taper core wire profile PressureWire Certus Step-wise core wire grinding profile New: Continuous Taper Core Wire Design • The PressureWireCertus Generation 7 is designed to offer: • Better translate rotational movement • Improve torque response

12. The optimized sensor to wire transition has been design to: Increase tip control Improve the Pressure Wires ability to navigate sharp angled side branches and reduces the risk for wire prolapse New: Optimized Sensor-to-Wire Transition PressureWireCertus Generation 7 PressureWireCertus

13. New: Packaging Tray • PressureWireCertus Generation 7 comes in a new plastic packaging tray which is designed to: • Simplify handling • Eliminate risk for accidental damage and • Provide better protection during transportation • Preparation procedure • Remove tray from sterile pouch using standard sterile technique • Place tray on cathlab table sterile dressing • Flush packaging coil with saline • Remove lid by pulling where indicated by arrow • Pull out instrument connector and connect to Analyzer • Calibrate PressureWire • Remove PressureWire from coil by pulling on the proximal female connector

14. Polymer sleeve Polymer Sleeve • The distal polymer sleeve on PressureWireCertus Generation 7 is designed to: • Increases signal reliability • Increases device compatibility • Increased space inside for cabling and a medium support corewire.

15. Hydrophilic coating Hydrophilic coating Hydrophilic Coating • The lubricious hydrophilic hyaluronan coating on PressureWireCertus is designed to: • Reduce friction • Lower the risk of tissue abrasion or device incompatibility • Increase pushability and tactile feel

16. Hydrophilic Coating The hydrophilic coating on PressureWireCertus Generation 7 has been found to significantly reduce friction in bench test models as compared to the non-hydrophilic Volcano Primewire Slydx. Vessel friction evaluated in bench model. The force required to pull each wire through a vessel fixture was measured. Data on file.

17. Hydrophobic connector Hydrophobic connector Hydrophobic Connector • The protective hydrophobic connector on PressureWireCertus is designed to: • Repel blood and fluids • Prevent leakage currents • Reduce the risk of signal problems

18. Hydrophobic Connector The hydrophobic connector on PressureWireCertus has been found to significantly reduce reconnection problems in wet conditions as compared to the non-hydrophobic connector on Volcano Primewire. * Re-connection of PressureWire Certus compared to Volcano Primewire after equal disconnection time in a wet condition to simulate actual use (measured in seconds). Data on file.

19. Large entry funnel Proximal Connector • The unique ergonomically designed proximal female connector on PressureWireCertus is designed • For fast and easy wire reconnection. • Reduce wire insertion friction • With an easier to use on/off locking mechanism

20. Versatile Multi-Functionality PressureWireCertus Generation 7 is the only pressure guidewire on the market offering FFR, CFR and IMR, all in one wire.

21. RadiAnalyzer™ Xpress RadiAnalyzer Xpress together with PressureWire Certus forms a versatile measurement system, capable of both everyday clinical decision-making as well as advanced physiological research.

22. Technical Specifications

23. Best In Class Handling Precise maneuverability to reach tortuous distal vessels and sharp angled side branches. Continuous taper core wire designNew! Optimized sensor-to-wire transitionNew! Hydrophilic coating Versatility The only pressure guidewire on the market offering (FFR), Coronary Flow Reserve (CFR), and Index of Microcirculatory Resistance (IMR). Reliability Unique design reduces risk for signal disturbances during long procedures and extensive handling in the cathlab environment. Summary PressureWireCertus Generation 7: