PressureWire™ Certus FFR Measurement System

Engineered for Exceptional Precision, Control and Reliability

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

Advanced Design for High Performance

Today's PressureWire Certus is an advanced generation technical design, featuring numerous enhancements and delivering handling performance that closely resembles standard 0.014" guidewires. The latest design refinements reflect our commitment to uphold the PressureWire heritage as a pioneer in the FFR market and continue providing interventional cardiologists with best-in-class pressurewire technologies.  

Optimized Handling Features

• New continuous-taper core wire provides excellent torque response fo rexcellent maneuverability in tortuous anatomies

• Optimized sensor-to-wire transition enhances ability to navigate sharp-angled side branches and makes PressureWire Certus less sensitive to prolapse 

Hydrophilic and Hydrophobic Coatings

Patented Sensor Technology

PressureWire Certus features a proprietary, miniaturized, high-fidelity pressure sensor for measurement of intravascular pressure for accurate FFR measurement.

The PressureWire Certus technology enables simultaneous measurement of temperature and thermo-dilution flow and concurrent gathering of FFR and CFR (coronary flow reserve).

 ^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.

³Data on file at St. Jude Medical

Knowledge Center

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

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 low 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.

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 Routinely 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 revascularization by 28%¹
• Improves outcomes and patient quality of life
• Lowers procedure and one-year follow-up costs by 14%
• Does not increase procedure time
• Decreases the amount of contrast agent used

The complex lesions evaluated in the FAME Study were successfully and exclusively measured by the St. Jude Medical PressureWire Certus FFR measurement system. 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.

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 efficient 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

One-year Outcomes

Compared to angiography-only procedures, FAME one-year results show 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

Two-Year Outcomes

Compared to angiography-only procedures, FAME two-year results show that FFR:

• Reduces mortality and myocardial infarction (combined) at two years by 34%
  
  
• Reduces myocardial infarction alone at two years by 37%
  
  
• Is cost-saving and improves procedure outcomes
  
  

Absolute Difference in MACE-free Survival at One Year

MACE

Two-year Survival Free of Death/MI

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.

Read more about the FAME study at famestudy.com.