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.
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”
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.
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.
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
The FAME Study Results
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.
PressureWire™Certus
The 7th Generation PressureWire
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.
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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
PressureWire Certus - Overview
Multi-function sensor:
FFR, CFR, IMR
New for Generation 7
Continuous taper core
wire design
New for Generation 7
Optimized sensor-to-wire
transition
Hydrophilic coating
Polymer sleeve
Hydrophobic connector
PTFE coating
Large entry funnel
New for
Generation 7
Packaging tray
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New: Continuous Taper Core Wire Design
The PressureWire Certus Generation 7 is designed to offer:
• Better translate rotational movement
• Improve torque response
PressureWire Certus Generation 7
Continuous taper core wire profile
PressureWire Certus
Step-wise core wire grinding profile
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New: Optimized Sensor-to-Wire Transition
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
PressureWire Certus Generation 7
PressureWire Certus
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New: Packaging Tray
PressureWire Certus 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
1.
2.
3.
4.
5.
6.
7.
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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
Polymer Sleeve
The distal polymer sleeve on PressureWire Certus Generation 7 is
designed to:
• Increases signal reliability
• Increases device compatibility
• Increased space inside for cabling and a medium support corewire.
Polymer sleeve
Hydrophilic Coating
The lubricious hydrophilic hyaluronan coating on PressureWire Certus is
designed to:
• Reduce friction
• Lower the risk of tissue abrasion or device incompatibility
• Increase pushability and tactile feel
Hydrophilic coating
Hydrophilic coating
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Hydrophilic Coating
The hydrophilic coating on PressureWire Certus Generation 7 has been
found to significantly reduce friction in bench test models as
compared to the non-hydrophilic Volcano Primewire Slydx.
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Vessel friction evaluated in bench model. The force
required to pull each wire through a vessel fixture was
measured. Data on file.
Hydrophobic Connector
The protective hydrophobic connector on PressureWire Certus is
designed to:
• Repel blood and fluids
• Prevent leakage currents
• Reduce the risk of signal problems
Hydrophobic connector
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Hydrophobic connector
Hydrophobic Connector
The hydrophobic connector on PressureWire Certus has been found to
significantly reduce reconnection problems in wet conditions as
compared to the non-hydrophobic connector on Volcano Primewire.
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* 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.
Proximal Connector
The unique ergonomically designed proximal female connector on
PressureWire Certus is designed
• For fast and easy wire reconnection.
• Reduce wire insertion friction
• With an easier to use on/off locking mechanism
Large entry funnel
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Versatile Multi-Functionality
PressureWire Certus Generation 7 is the only pressure guidewire on the
market offering FFR, CFR and IMR, all in one wire.
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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.
RadiView
PhysioMon
Thermo Option
Printer Kit
Technical Specifications
Summary PressureWire Certus Generation 7:
Best In Class Handling
Precise maneuverability to reach tortuous distal vessels and sharp angled side branches.
Continuous taper core wire design
Optimized sensor-to-wire transition
Hydrophilic coating
New!
New!
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.
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