PressureWire™ Certus FFR Measurement System

This device is commercially available for use in the United States and select international markets.

Reliable, Accurate FFR Measurement For Complex Coronary Lesion Assessment

PressureWire Certus

The market-leading PressureWire Certus FFR Measurement System measures fractional flow reserve (FFR), which has been shown1 to more accurately assess the severity of individual ischemia-causing lesions. Routine use of PressureWire Certus for FFR measurement offers physicians more control when assessing complex coronary lesions, increasing the efficiency and efficacy of coronary revascularization. Its design features a hydrophilic sleeve and hydrophobic coating at connector points for enhanced maneuverability, control and reliability.

1Tonino PA, De Bruyne B, Pijls NH, et al. Fractional low reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-224.

Incorporating FFR Measurement into Procedures Significantly Reduces Major Adverse Coronary Events1

When integrated into 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 more accurate identification of hemodynamically relevant stenoses, reducing rates of death, myocardial infarction and repeat revascularization2
  • Improves outcomes and patient quality of life
  • Lowers procedure-related costs
  • Does not increase procedure time
  • Decreases the amount of contrast agent used

Precise measurement of intravascular pressure relies on the market-leading wire that combines exceptional maneuverability–even in tortuous vessels–and reliable readings to ensure access to accurate information in the cath lab.

Patented Sensor Technology

PressureWire Certus features a proprietary, miniaturized, high-fidelity pressure sensor for measurement of intravascular pressure for accurate FFR measurement. This technology also enables simultaneous measurement of temperature and thermo-dilution low, which can be stored on the RadiAnalyzer Xpress.

 PressureWire Certus sensor

Engineered for Exceptional Precision, Control and Reliability

The PressureWire Certus is a reliable, accurate FFR measurement system for complex coronary lesion assessment.

Core Wire

Strengthened core 0.014" wire provides increased torque, making PressureWire Certus less sensitive to prolapse.

Hydrophilic and Hydrophobic Coatings

  • Distal polymer sleeve is coated with a hydrophilic outer layer which reduces friction against the vessel wall and increases device compatibility
  • A hydrophilic coating enhances overall maneuverability in tortuous vessels by providing better tactile feel and distal access
  • The proximal male connector has a hydrophobic coating which increases connector reliability during long procedures

 PressureWire Certus Coatings

1,2Tonino PA, De Bruyne B, Pijls NH, et al. Fractional low reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-224.

Learn more on our Knowledge Center

Find out more about Physiological Assessment using a guidewire-mounted pressure sensor and its clinical applications in the catheterization laboratory.
Click here to go to our Knowledge Center

Order Number Description Pressure Range Pressure Accuracy

Frequency Response

Spec Sheet

12006

 

12306

PressureWire Certus (175 cm)

PressureWire Certus (300 cm)

-30 to +300 mmHg +/-1 mmHg plus
+/-1% of reading
(-30 to 50 mmHg)
+/-3% of reading (50 to 300 mmHg)
0– 25 Hz PressureWire Certus Spec Sheet [PDF]

Fractional Flow Reserve (FFR) Measurement for Informed Coronary Disease Intervention

 FFR

FFR Measurement Correlates to the Likelihood of Ischemia

An FFR measurement above 0.80 indicates normal coronary blood low and a non-significant stenosis. A measurement below 0.75 indicates a high likelihood that a stenosis may be causing ischemia.

 FFR Measurement

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 30% reduction in major adverse cardiac event (MACE) rates and significant cost savings without prolonging procedure time.

1Tonino PA, De Bruyne B, Pijls NH, et al. Fractional low reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-224.

Study Reports Integrating FFR into Procedures Improves Outcomes and Reduces Costs

The FAME study, recently 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 eficient and more cost-effective.1

FAME Study Results

Study Methods

  • FAME (FFR versus Angiography for Mutilvessel Evaluation)
  • Randomized, prospective study – angiography only or angiography plus FFR
  • 20 centers in US 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

FAME Study results 

1Tonino PA, De Bruyne B, Pijls NH, et al. Fractional low reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-224.

FAME Study

Read more about the FAME study at www.famestudy.com

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