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QUANTIEN™ Integrated FFR System

This device is commercially available for use in select international markets.

The wireless design of the QUANTIEN integrated FFR system allows you to configure your cath lab environment exactly the way you like – without the clutter of cables.

Wireless AO pressure from Wi-Box unit

Wireless communication with PressureWire Aeris guidewire

DICOM Worklist and DICOM Archive functionality
Smooth touch screen
Case annotations
Export to several different destinations and formats
Customized installations
Overview

Free Your Cath Lab with Wireless FFR

Fast and Easy FFR Integration

Quantien Fast and Easy FFR Integration  

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The wireless design of the QUANTIEN integrated FFR system allows you to configure your cath lab environment exactly the way you like – without the clutter of cables.

Easy cath lab installation gives you full FFR integration without cabling through floor or ceiling – and without cath lab downtime.

With the wireless Wi-Box™ unit and PressureWire™ Aeris™ guidewire, the QUANTIEN main unit can be placed as a built-in or mobile device anywhere in the cath lab, freeing up valuable table space and allowing control by either sterile- or nonsterile-dressed staff. PressureWire™ Certus™ guidewire can be used if QUANTIEN main unit is mounted bedside or placed close by the cath lab table on a pole.

Hyperemic and Resting Indices

QUANTIEN system supports measurement and documentation of both FFR with hyperemia, and Pd/Pa at resting conditions.

Fast and Easy Wireless FFR

With the QUANTIEN system, FFR is always available when and where you want it, without time-consuming setup or cables.

Easy to Place

Place it where you want it – on a desktop, on a wall, bedside or on a mobile pole.

Full Visibility

Regardless of where you place the QUANTIEN main unit, you can view its video screen on the existing cath lab monitors right next to your angio and hemo screens.

Touch Display

You have fingertip access to all features, using the latest touch screen technology and a high-resolution widescreen.

Full Connectivity

Quick and easy procedures and full case documentation with DICOM Worklist, DICOM Archive, local network and USB memory stick data export.

Learn More at Our Knowledge Center

Find out more about physiological assessment using a guidewire-mounted pressure sensor and its clinical applications in the catheterization laboratory. 


MATERIALS & LINKS

Tech Specs

QUANTIEN™ Integrated FFR System

Instrumentation

Ordering Information    View Catalog

Contents: QUANTIEN™ Integrated FFR System (1 unit per box)
Power cable (EU, UK, US) (3 units)
Ethernet Patch cable

Note: – Requires AO-pressure from Wi-Box unit (C12783) or via cable with AUX IN cable kit
– Delivered without mounting bracket. Ordered from St. Jude Medical or using third-party standard VESA 75x75 or 100x100 mm mounting bracket.

Reorder Number Description
C12787 QUANTIEN™ Integrated FFR System
Evidence

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

FFR Measurement for Informed Coronary Disease Intervention

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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.1

FFR Measurement Correlates to the Likelihood of Ischemia

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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.2

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.2

Our Claim to FAME and FAME 2

FAME

Compared to angiography alone, FFR2:

  • 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
  • No increase in procedure time
  • Decreases the amount of contrast agent used
FAME 2

FFR-guided PCI using PressureWire guidewire is a cost-effective strategy that improves outcomes and quality of life compared to medical therapy alone.3,4

  • 77% relative reduction in the risk for ACS requiring unplanned hospital readmission with urgent revascularization
  • Greater relief of angina
  • Cost-effectiveness ICER of $32,000 per QALY

References

1.  Pijls NHJ ,et al. N Eng J Med 1996;334;26:1703-08.
2. Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. FAME study. N Engl J Med. 2009;360(3):213-24.
3. De Bruyne B, Pijls N, Kalesan B, et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012;367(11):991-1001.
4. Fearon F, et al. Cost-Effectiveness of Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease and Abnormal Fractional Flow Reserve (FAME 2). Circulation. 2013;128:1335-1340.


MATERIALS & LINKS

Indications, Safety & Warnings
Print

QUANTIEN™ Integrated FFR System

Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

PressureWire™ Aeris™ and PressureWire™ Certus™ guidewires, QUANTIEN system and Wi-Box™ unit are designed, developed and manufactured by St. Jude Medical. Product referenced is approved for CE Mark.

Indications

QUANTIEN system is indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters with PressureWire guidewire.

QUANTIEN system is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers or measuring devices.

Contraindications

The device has no patient alarm functions. Do not use for cardiac monitoring.