PressureWire Aeris with Agile Tip Technology. Wireless FFR Functionality and Handles like a Workhorse PCI Guidewire 1

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1 Home» Products» All International Products» PressureWire Aeris with Agile Tip Technology PressureWire Aeris with Agile Tip Technology This device is commercially available for use in select international markets. Wireless FFR Functionality and Handles like a Workhorse PCI Guidewire 1 St. Jude Medical continues to set new standards in fractional flow reserve (FFR) assessment. With the next generation PressureWire and proprietary Agile Tip technology, physicians now have a new, more responsive pressure guidewire that provides outstanding handling even in challenging anatomies. 1. St. Jude Medical. Data on File: R3149 PressureWire Generation 8 PMS Report. Product Overview Fast and Easy FFR Outstanding Handling Performance PressureWire with Agile Tip is designed to allow physicians to quickly and easily navigate tortuous vessels, which may reduce procedure time and eliminates the need for additional delivery devices. Round tip profile with Agile Tip technology compared to previous flat wire tip Symmetrical rotation regardless of angulation Improved steering response in sharp bends and acute takeoffs Superior Torque Response The unique new tip from St. Jude Medical features a proprietary round core-to-tip grinding profile that provides extraordinary agility and a near 1:1 torque response in sharp bends and tortuous vessels. As a result, PressureWire with Agile Tip enables smooth and accurate vessel navigation compared to competitive pressure guidewires that deliver a typical whipping effect when torque is built up gradually before being released. 1

2 Easier Navigation and Deivce Delivery The new PressureWire features a specially developed hydrophilic coating that lowers friction between guidewire and guide catheter as well as between guidewire and stent delivery catheters. 1 This new, lubricious coating gives PressureWire lower guide friction and better decice delivery compared to other pressure guidewires. 1 True FFR Simulated clinical use shows that FFR measurement using PressureWire Certus from St. Jude Medical is more reliable, with an average of 2.6 times lower pressure drift per hour as compared to competitive pressure guidewires. 2 More than FFR Unique multi-functionality with proprietary sensor chip technology enables assessment of multiple parameters with one wire. PressureWire Aeris with Agile Tip is the only wireless FFR device with multiple platform compatibility, including all major hemodynamic recording systems and the

3 ILUMIEN PCI optimization system. PressureWire Aeris Wireless System Components PressureWire Aeris PressureWire Aeris Hemodynamic Recording Transmitter Receiver System 1. St. Jude Medical. Data on File: R3149 PressureWire Generation 8 PMS Report. 2. St. Jude Medical. Data on File. Average pressure drift from 25 competitive pressure guidewires and 50 PressureWire Certus during one-hour simulated clinical use in heparinized blood. Knowledge Center Find out more about physiological assessment using a guidewire-mounted pressure sensor and its clinical applications. Go to the Knowledge Center. PrimeWire Prestge is a registered or unregistered trademark of Volcano Corporation. Technical Specifications Order Number Description Pressure Range Pressure Accuracy Frequency Response C12058 PressureWire Aeris (175 cm) -30 to +300 mmhg +/-1 mmhg plus +/-1% (<50 mmhg) +/-3% (>50 mmhg) DC to 25 Hz Order Number Description C17040 PressureWire Receiver How it Works Fractional Flow Reserve (FFR) Measurement for Informed Coronary Disease Intervention FFR Measurement Correlates to the Likelihood of Ischemia An FFR measurement above 0.80 indicates normal coronary blood flow and a nonsignificant stenosis. A measurement below 0.75 indicates a high likelihood that a stenosis may be causing ischemia.

4 Incorporating FFR Measurement into Procedures Significantly Reduces Major Adverse Coronary Events When integrated into routine lab procedures, measurement of fractional flow reserve (FFR) has been shown to reduce the incidence of adverse events in patients being treated for complex coronary artery disease. Compared to angiography alone, FFR allows physicians to more accurately identify hemodynamically relevant stenoses, reducing rates of death, myocardial infarction and repeat revascularization. 1 Key findings from the FAME study show a 28% reduction in major adverse cardiac event (MACE) rates and significant cost savings without prolonging procedure time. 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): Clinical Data Study Reports Integrating FFR into Procedures Improves Outcomes and Reduces Costs The FAME study, 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. 1 FAME Study Results Study Methods FAME (FFR versus Angiography for MultiVessel Evaluation) Randomized, prospective study angiography only or angiography plus FFR 20 centers in U.S. and Europe 1,005 PCI patients undergoing DES stenting for multivessel disease Outcomes Compared to angiography-only procedures, FAME shows 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

5 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): Read more about the FAME study 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.