PressureWire X Guidewire
VASCULAR
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The innovative PressureWire System with the PressureWire X guidewire—together with a fractional flow reserve (FFR)-enabled hemodynamic recording system—offers fully integrated wireless FFR measurement. The system’s secure, wireless FFR data are an integral part of any cardiac cath lab’s clinical routine.

 

PRESSUREWIRE X FOR IMPROVED CARDIAC CATH LAB WORKFLOW

The PressureWire X system uses existing hardware and screens to enable the recording system to display FFR information inside the cardiac cath lab as well as the control room. All FFR results are stored with procedural data for a more complete patient record.

With the PressureWire X system there is no need for stand-alone FFR instrumentation or time-consuming setup. The secure, wireless technology eliminates cables crossing the sterile field, and there is no cable to limit wire maneuverability.

HANDLING PERFORMANCE

This newest generation of PressureWire technology offers:

  • A hydrophilic coating that significantly lowers friction and enables smoother stent delivery and better overall maneuverability1
  • Improved shapeability and reshapeability for smooth navigation1
  • Better shape retention for performance in complex anatomy and for multiple pull-backs1
  • More durable soft tip designed to protect the vessel in tortuous anatomy without compromising steerability/trackability1

ACCURATE AND RELIABLE

The PressureWire X is the only pressure wire technology clinically proven in both FAME and FAME 2 studies.2-4


References

1. Data on file at Abbott
2. Tonino PA, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary iIntervention. New Engl J Med. 2009;360:213-224. doi: 10.1056/NEJMoa0807611.
3. Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME study. J Am Coll Cardiol. 2010;56(3):177-184. doi: 10.1016/j.jacc.2010.04.012.
4. de Bruyne B, et al. Fractional flow reserve–guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012;367(11), 991–1001. doi: 10.1056/NEJMoa1205361.

USE OF PHYSIOLOGY SIGNIFICANTLY REDUCES MAJOR ADVERSE CORONARY EVENTS

Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is the gold standard for lesion assessment, supported by more than 600 published studies including the FAME clinical trials.1-3

When integrated into cardiac cath lab procedures, measurement of FFR has been shown to reduce the incidence of major adverse coronary events (MACE) in patients being treated for complex coronary artery disease.

The FAME study—evaluating complex lesions—examined FFR measured exclusively by the PressureWire Certus System. Results showed that compared to angiography alone, FFR:

  • Allows more accurate identification of hemodynamically relevant stenoses1
  • Reduces mortality and myocardial infarction by 34%2
  • Lowers procedure and 1-year follow-up costs by 14%1
  • Does not increase procedure time1
  • Decreases the amount of contrast agent used1

Precise measurement of intravascular diagnostics relies on the market-leading PressureWire X guidewire that combines excellent maneuverability—even in tortuous vessels—and reliable readings, all of which can ensure accurate information in the cath lab.


References

1. Tonino PA, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary iIntervention. New Engl J Med. 2009;360:213-224. doi: 10.1056/NEJMoa0807611.
2. Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up of the FAME study. J Am Coll Cardiol. 2010;56(3):177-184. doi: 10.1016/j.jacc.2010.04.012.
3. de Bruyne B, et al. Fractional flow reserve–guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012;367(11), 991–1001. doi: 10.1056/NEJMoa1205361.

SYSTEM COMPONENTS FOR WIRELESS INTEGRATED FRACTIONAL FLOW RESERVE (FFR)

Components for intravascular diagnostics include the following

PressureWire X System

  • Pressure guidewire connects wirelessly with PressureWire Receiver
  • Advanced radio technology for secure communication
  • Hydrophilic-coated guidewire design for exceptional handling performance
  • Visual physiological data from the PressureWire X guidewire via QUANTIEN or the PressureWire Receiver
PressureWire Transmitter, PressureWire Receiver, and hemodynamic recording

THE PRESSUREWIRE X GUIDEWIRE IN THE CATH LAB

PressureWire Transmitter, PressureWire Receiver, and hemodynamic recording


SECURE COMMUNICATION

The PressureWire transmitter and receiving system lock to each other at calibration using a unique identification code. The receiver cannot receive pressure from any other PressureWire X guidewire used simultaneously in the same environment.

Other elements to ensure secure communication include the following:

  • The system uses advanced frequency-hopping spread spectrum (FHSS) technology and very low radio power to avoid interfering with or being disturbed by other systems in the cardiac cath lab.
  • The system changes radio frequency 400 times per second so that even if there are several interfering radio sources it will always locate alternate free frequencies.
  • Mobile phones, computer networks or x-ray equipment will not disturb the radio signal.
  • The PressureWire X guidewire uses extremely low transmitted radio power—1,000 to 10,000 times lower than the power from a normal cellular phone—to reduce the possibility of disturbing other systems.
  • If a power failure occurs, the receiving system stores the last connected PressureWire X guidewire in its memory for automatic reconnection.
  • The PressureWire X guidewire has passed all radio acceptance tests by EU R&TTE and US FCC.

* Pa: proximal coronary pressure; Pd: distal coronary pressure
‡ Indicates a third party trademark, which is property of its respective owner

ORDERING THE PRESSUREWIRE X GUIDEWIRE

PRODUCT MODEL / REORDER NUMBER
PressureWire X Guidewire, 175 cm C12059
PressureWire X Guidewire, 300 cm C12359
PressureWire Receiver C17040

PressureWire X Compatible Recording System Cable Ordering #
Philips Xper Flex Cardio‡ C12916
Fysicon QynetiQ CVIS‡ Contact vendor
Siemens AXIOM Sensis 10 pin‡ C12901
Siemens AXIOM Sensis 7 pin‡ C12849
GE Mac-Lab‡ C12918
McKesson Horizon Cardiology‡ C12951
Merge HeartSuite‡ C12951
CathMed Picasso‡ C12951
Ortivus CoroNet PCI‡ Contact Vendor
Mennen Horizon XVu‡ C12954

TECHNICAL SPECIFICATIONS
(Specifications for the combination of
PressureWire X Guidewire and PressureWire Receiver)
Pressure range -30 to +300 mmHg
Pressure accuracy ±1 mmHg plus ± 1% (<50 mmHg) ± 3% (>50 mmHg)
Frequency response DC to 25 Hz
Battery time transmitter 3 hours
Frequency range 2.4000-2.4835 GHz (ISM band)
Radio type Frequency-hopping spread spectrum (FHSS)
Radio power 1 mW peak, 70 μW average
Total signal time delay < 10 ms

‡Indicates a third party trademark, which is property of its respective owner

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INDICATIONS AND IMPORTANT SAFETY INFORMATION

rx-only-logo PressureWireTM X Guidewire

INDICATIONS

The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.

CONTRAINDICATIONS

This guidewire is contraindicated for use in the cerebral vasculature.

WARNINGS

  • No modification of this device is allowed.
  • The PressureWire™ X guidewire is supplied sterile. Discard the guidewire if the pouch is opened or damaged, compromising the sterile barrier. The guidewire is designed for single use only and shall not be reused or resterilized. Adverse effects of using a non-sterile or resterilized guidewire may include, but are not limited to:
    • Local and/or systemic infection
    • Mechanical damage
    • Inaccurate readings
  • Observe all guidewire movements. Whenever the guidewire is moved or torqued, the tip movement should be examined under fluoroscopy. Never push, withdraw, or torque the guidewire if it meets resistance or without observing corresponding movement of the tip, otherwise vessel/ventricle trauma may occur.
  • Torquing or excessive manipulation of the guidewire in a sharp bend, against resistance, or repeated attempts to cross a total vessel occlusion may:
    • Cause dissection or perforation of blood vessels
    • Cause vessel spasm
    • Damage and/or fracture the guidewire
  • When introducing the guidewire, flush the catheter and administer anticoagulation as for a standard catheterization procedure or clotting may occur.
  • Do not use the guidewire in the ventricles if the patient has a prosthetic mechanical or biological valve. It may result in damage to both the prosthesis and the guidewire, which may cause injury or death.
  • Use of the PressureWire™ X guidewire in conjunction with interventional devices with a short rapid exchange may result in a folded or fractured guidewire.
  • High frequency surgical devices must not be used on a patient at the same time as the guidewire.

PRECAUTIONS

  • The PressureWire™ X guidewire is a delicate instrument and should be handled carefully.
  • Make sure that the transmitter is kept dry to ensure accurate pressure and/or temperature readings. Inaccurate readings may necessitate device replacement.
  • Do not use the guidewire in conjunction with atherectomy catheters. It may damage the guidewire.
  • Do not withdraw or manipulate the guidewire in a sharp-edged object. It may result in abrasion of the guidewire coating.
  • Factors that may affect the accuracy of the diagnostic information include, but are not limited to:
    • Improper placement of the aortic pressure sensor.
    • Failure to achieve maximum coronary and myocardial hyperemia.
    • Blood flow affected by the position of interventional devices, such as balloon catheters.
  • Guidewire readings may be affected by defibrillation. Rezero the guidewire after defibrillation use.
  • Do not measure pressure when the guidewire sensor element is in a sharp bend or in contact with atrial or ventricular walls. It might result in pressure artifacts.
  • Do not use the PressureWire™ X guidewire together with another guidewire, for so called jailed wire technique, due to difficulty in guidewire withdrawal and possible guidewire entrapment.
  • Store at room temperature in a dry and dark place.

POTENTIAL ADVERSE EVENTS

Potential complications which may be encountered during all catheterization procedures include, but are not limited to: vessel dissection or occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, congestive heart failure, myocardial infarction, hypotension, chest pain, renal insufficiency, serious arrhythmias, or death.

AP2946266-WBU Rev. A

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