CARDIOVASCULAR
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Abbott’s newest generation of the PressureWire™ X Guidewire offers objective decisions with a simplified workflow.

The innovative PressureWire™ X Guidewire—the world’s only wireless pressure wire1 – assesses hemodynamics using either Abbott’s Resting Full-Cycle Ratio (RFR) or Fractional Flow Reserve (FFR) measurement. The guidewire’s fully integrated, secure, wireless FFR or RFR measurements are integral to a cardiac cath lab’s clinical routine.

Objective Decisions. Simplified Workflow.

Abbott’s newest generation of the PressureWire™ X Guidewire offers objective decisions with a simplified workflow.

Objective Decisions

  • Innovative sensor housing design offers <1mmHg/30 min with an 84% reduction in drift due to microbubbles2
  • Seamlessly switch between FFR and RFR
  • RFR has been studied in over 3,500 lesions and 2,000 patients3-7 to show diagnostic equivalence to iFR.

Previous Design

Previous 1-hole design

Sampling of 25 wires

New PressureWire™ X Guidewire

New PressureWire X 3-Hole Design

Sampling of 25 wires

Bench testing data designed to simulate the cath lab environment. Test(s) performed by and data on file at Abbott.


 

Traditional Sensor Housing Designs

Previous generation PressureWire™ X Guidewire1, Verrata Plus1, OptoWire Deux1, and Comet Wire1

Traditional sensor housing design


 

Abbott’s Innovative Sensor Housing Design

PressureWire™ X Guidewire1
 

Abbot's innovative sensor housing design


 

Simplified Workflow

  • The Pressure Wire™ X Guidewire is the world’s only wireless physiology pressure wire1
  • Wireless: from zero to go in 2 easy steps1
  • Ideal for modern radial approach­
  • Compatible with the integrated QUANTIEN™ Measurement System with an easy touchscreen workflow
  • Compatible with OPTIS™ Imaging System for imaging and physiology needs on one platform
Wireless PressureWire X Guidewire
2 Steps to Connect the Wireless PressureWire™ X Guidewire1
  1. Zero. Zero the PressureWire™ X Guidewire by turning on the transmitter.
  2. Go. The transmitter’s function indicator shall display a stable green light when it is successfully zeroed.
REFERENCES

1. Volcano Corp. Verrata‡ guidewire and PrimeWire Prestige‡ Plus guidewire IFUs, Opsens Inc. OptoWire‡ guidewire and OptoWire‡ II guidewire IFUS, ACIST Medical Systems. Navvus‡ Microcatheter IFU, Boston Scientific Corporation. Comet‡ guidewire IFU, PressureWire™ X guidewire IFU.
2. Test(s) performed by and data on file at Abbott.
3. Jeremias A, et al. Resting full-cycle ratio (RFR): a novel physiologic index compared to Fractional Flow Reserve (FFR) in assessing the hemodynamic severity of a coronary stenosis: ILUMIEN I + PREDICT. EuroPCR 2018.
4. Svanerud J, et al. Validation of a novel non-hyperaemic index of coronary artery stenosis severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. EuroIntervention. 2018;14:806-814.
5. Ahn JM, et al. IRIS FFR: prognostic performance of five resting pressure-derived indexes of coronary physiology. TCT 2018.
6. Data on file at Abbott.
7. Lee J-M, et al. Physiological and clinical assessment of resting physiological indexes. Circulation. 2019;139.

USE OF PHYSIOLOGY SIGNIFICANTLY REDUCES MAJOR ADVERSE CORONARY EVENTS

RFR clinical evidence derives from assessing over 3,500 lesions in 2,000 patients,2-6 and much of that evidence is from ILUMIEN I + PREDICT, VALIDATE RFR, IRIS-FFR and RE-VALIDATE RFR.

Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) for lesion assessment has been supported by more than 600 published studies including the FAME clinical trials.7-9

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 stenoses7
  • Reduces mortality and myocardial infarction by 34%8
  • Lowers procedure and 1-year follow-up costs by 14%7
  • Does not increase procedure time7
  • Decreases the amount of contrast agent used7

REFERENCES

1. Volcano Corp. Verrata‡ guidewire and PrimeWire Prestige‡ Plus guidewire IFUs, Opsens Inc. OptoWire‡ guidewire and OptoWire‡ II guidewire IFUS, ACIST Medical Systems. Navvus‡ Microcatheter IFU, Boston Scientific Corporation. Comet‡ guidewire IFU, PressureWire™ X guidewire IFU.
2. Jeremias A, et al. Resting full-cycle ratio (RFR): a novel physiologic index compared to Fractional Flow Reserve (FFR) in assessing the hemodynamic severity of a coronary stenosis: ILUMIEN I + PREDICT. EuroPCR 2018.
3. Svanerud J, et al. Validation of a novel non-hyperaemic index of coronary artery stenosis severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. EuroIntervention. 2018;14:806-814.
4. Ahn JM, et al. IRIS FFR: prognostic performance of five resting pressure-derived indexes of coronary physiology. TCT 2018.
5. Data on file at Abbott.
6. Lee J-M, et al. Physiological and clinical assessment of resting physiological indexes. Circulation. 2019;139.
7. 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.
8. 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.
9. 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.

Set Up For Wireless Integrated FFR And RFR

Coronary physiology can be achieved using either FFR or RFR measurements.

  • PressureWire™ X Guidewire connects wirelessly with PressureWire™ Receiver.
  • Advanced radio technology allows for secure communication.
  • Visual physiological measurements are available via QUANTIEN™ Measurement System or the PressureWire™ Receiver.
  • Using existing hardware and screens, the PressureWire™ X Guidewire displays FFR or RFR measurements in the cardiac cath lab as well as the control room.
  • All FFR/RFR results are stored with procedural data to provide a complete patient record.
PressureWire Transmitter, PressureWire Receiver, and hemodynamic recording

ADVANCED WIRE TECHNOLOGY
  • Uniquely designed sensor housing for improved drift performance2
  • Wireless design optimal for procedures using
    radial approach

ADVANCED PATIENT SECURITY
  • Enhanced login and encryption features3
  • Wireless signal uses advanced frequency-hopping spread spectrum (FHSS) technology that changes radio frequency 400 times per second

THE PRESSUREWIRE™ X GUIDEWIRE IN THE CATH LAB

Wireless PressureWire™ X can employ both FFR and RFR™ data


SECURE COMMUNICATION

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

These factors also aid in ensuring secure communication:

  • 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.

REFERENCES

1. Volcano Corp. Verrata‡ guidewire and PrimeWire Prestige‡ Plus guidewire IFUs, Opsens Inc. OptoWire‡ guidewire and OptoWire‡ II guidewire IFUS, ACIST Medical Systems. Navvus‡ Microcatheter IFU, Boston Scientific Corporation. Comet‡ guidewire IFU, PressureWire™ X guidewire IFU.
2. Compared to the previous generation (PressureWire™ 8 Guidewire); Test(s) performed by and data on file at Abbott.
3. Compared to the previous generation QUANTIEN™ Measurement System.

 

BE CONFIDENT IN YOUR RESTING INDEX DECISION-MAKING with Abbott’s Pressure Wire™ X Guidewire: Abbott’s innovative sensor housing designs offers <1mmHg/30 minutes with an 84% reduction in drift due to microbubbles.2

Drift is an issue that can lead to misclassification of stenosis.

There are two types of drift: wire-related (true drift) and procedure-related (apparent drift). While there are multiple causes of procedure-related drift, microbubbles (from residual air in device) are a major cause of drift5. Clinically significant drift is classified as ≥3 mmHg1

Drift affects the accuracy of most pressure measurement devices.3 Accuracy is particularly critical for resting indices, as clinical decisions from resting indices are more impacted by drift than FFR4,5. Compared to the hyperemic state, smaller separation between Pa and Pd at rest means it is critical to detect even the slightest difference of pressure.


 

The Effect of Drift on Stenosis Misclassification by Physiology Index3

Chart showing effect of drift on stenosis misclassification by physiology index

The Distribution of Values for FFR, IFR Aand Whole-Cycle PD/PA3

Set of charts showing the distribution of values for FFR, IFR and whole-cycle PD/PA
REFERENCES

1. Volcano Corp. Verrata‡ guidewire and PrimeWire Prestige‡ Plus guidewire IFUs, Opsens Inc. OptoWire‡ guidewire and OptoWire‡ II guidewire IFUS, ACIST Medical Systems. Navvus‡ Microcatheter IFU, Boston Scientific Corporation. Comet‡ guidewire IFU, PressureWire™ X guidewire IFU.
2. Test(s) performed by and data on file at Abbott.
3. Jeremias, A. et al. A Test in Context: FFR: Accuracy, Prognostic Implications, and Limitations. JACC 2017; 69:2748-58.
4. Van’t Veer, M. et al. JACC. Comparison od Different Diastolic Resting Indexes to iFR. 70 (25), 2017.
5. Cook, C. CCI. Quantification of the Effect of Pressure Wire Drift on the Diagnostic Performance of FFR, iFR & Pd/Pa.

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


REFERENCES

1. Volcano Corp. Verrata‡ guidewire and PrimeWire Prestige‡ Plus guidewire IFUs, Opsens Inc. OptoWire‡ guidewire and OptoWire‡ II guidewire IFUS, ACIST Medical Systems. Navvus‡ Microcatheter IFU, Boston Scientific Corporation. Comet‡ guidewire IFU, PressureWire™ X guidewire IFU.

QUESTIONS?

We are proud of the quality of our products and services, and remain committed to providing exceptional support and assistance to our customers across the globe.

For ordering information,
visit ordering.

For technical issues and product questions of a technical nature, visit support.

IMPORTANT SAFETY INFORMATION

rx-only-logo PressureWire™ 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.

AP2946417-WBU Rev. D

IMPORTANT SAFETY INFORMATION

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.