ILUMIEN™ System – Know which
lesion to treat and how to treat it.

PressureWire™ Aeris Wireless FFR Measurement System

This device is commercially available for use in the United States.

Integrated FFR Measurement For Complex Coronary Lesion Assessment

PressureWire Aeris

The PressureWire Aeris Wireless FFR Measurement System wirelessly measures fractional flow reserve (FFR), which has been shown1 to help guide stent placement. Routine use of PressureWire Aeris for FFR measurement offers physicians more control when assessing complex coronary lesions, increasing the efficacy and efficiency of coronary revascularization. PressureWire Aeris provides instant, wireless integration of crucial FFR data directly into the GE Mac-Lab® hemodynamic recording system for simplified cath lab workflow and optimum efficiency. A software upgrade allows FFR results to be stored in the existing hemodynamic recording archive with other procedural data for a more complete patient record.

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.

Incorporating FFR Measurement into Procedures Significantly Reduces Major Adverse Coronary Events by 28%1

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 revascularization1
  • 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 a system that combines exceptional maneuverability—even in tortuous vessels—and reliable readings to ensure access to accurate information in the cath lab.

PressureWire Aeris Enhances Cath Lab Eficiency

Instant access to FFR information improves cath lab workflow and simplifies the FFR procedure by eliminating the need for stand-alone instrumentation and additional equipment setup. PressureWire Aeris radio technology eliminates the potential of cables crossing the sterile field, and also automatically stores results with other procedure data for a complete patient record.

GE Mac-Lab® Upgrade for Wireless FFR

  • FFR is displayed in real time using existing screens in both the control room and cath lab
  • Integrated calculation provides fast, adaptive pressure averaging and pressure equalization
  • FFR results are synchronized with angiography and stored in existing archives with other procedural data

PressureWire Aeris Wireless System Components

 PressureWire Aeris
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.

Knowledge Center

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

Order Number Description Pressure Range Pressure Accuracy Frequency Response

12056

12356

PressureWire Aeris (175 cm)
PressureWire Aeris (300 cm)
-30 to +300 mmHg +/-1 mmHg plus
+/-1% (<50 mmHg)
+/-3% (>50 mmHg)
DC to 25 Hz

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 flow and a non-significant stenosis. A measurement below 0.75 indicates a high likelihood that a stenosis may be causing ischemia.

 

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):213-224.

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 eficient and more cost-effective1.

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 flow 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 on www.famestudy.com

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