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CARDIOVASCULAR

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Go Beyond the Angiogram

With Comprehensive Physiology

Go Beyond the Angiogram
Physiology Indices

Assess for the Root Cause of Angina

Angiography is often used for diagnosing coronary artery disease, but is unable to accurately capture the plaque morphology and eccentricity of an epicardial stenosis. As a result, angiography alone cannot be used to objectively provide a comprehensive assessment of both the epicardial arteries and the microvasculature.1

A comprehensive physiology assessment enables interventional cardiologists (ICs) to:

  • Go beyond the angiogram
  • Diagnose and treat only functionally significant epicardial lesions at stress or rest2,3
  • Diagnose microvascular disease in order to optimize patient management4

Watch physician experts discuss important factors to look for when measuring coronary physiology and explain why technique and the right tools matter.

Physiology-Guided Decision Making Leads to Better Outcomes5,6

The benefits of using coronary physiology include:

  • Coronary angiography is not accurate in 34% of cases compared to Fractional Flow Reserve (FFR)7
  • FFR physiology-guided percutaneous coronary intervention (PCI) reduces myocardial infarction (MI) compared to medical therapy alone8
  • All No-Hyperemic Pressure Ratios (NHPR), including Resting Full-cycle Ratio (RFR), have similar outcomes and diagnostic performances6
  • Adequate evaluation and optimal treatment of patients who have ischemia with no obstructive coronary artery disease (INOCA) can relieve patient symptoms, improving Quality of Life4

A Solution for Assessing Both the Epicardial Arteries and the Microvasculature9,10

With its pressure and temperature sensors, PressureWire™ X Guidewire has the capability to measure the entirety of the coronary circulation:9,10

  • Pressure can be used to measure FFR, Pd/Pa, and RFR
  • Temperature can be used to measure Index of Microcirculatory Resistance (IMR) and Coronary Flow Reserve (CFR) using thermodilution

PressureWire™ X Guidewire has been extensively studied and clinically validated in both stable and acute coronary syndrome (ACS) patients.5,11-12


PressureWire™ Guidewire: 20 Years of Evidence

PressureWire™ Guidewire: 20 Years of Evidence
Multiple Connection Options Offer Stress Free Connectivity

PressureWire™ X Guidewire is the only9 wire with multiple connection options to eliminate clutter and meet your lab's needs.

Catheterization Laboratory

References

  1. Topol EJ., et al. Our Preoccupation With Coronary Luminology. Circulation. 1995; 92(8): 2333-2342.
  2. Pijls N, et al. Measurement of Fractional Flow Reserve to Assess the functional severity of Coronary Artery Stenoses. N Eng J. 1996; 334 (1703-1708).
  3. Xaplanteris P, et al. FAME 2, Five-year outcomes with PCI guided by fractional flow reserve. N Engl J Med. 2018; 379:250-259
  4. Ford, TJ., et al. 1-year outcomes of angina management guided by invasive coronary function testing (CorMicA). J Am Coll Cardiol Intv. 2020; 13:33-45.
  5. 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 results of FAME study. J Am Coll Cardiol. 2010;56:177-184.
  6. Ahn JM, et al. IRIS FFR: prognostic performance of five resting pressure-derived indexes of coronary physiology. TCT 2018.
  7. Corcoran et al. Fractional Flow Reserve: A Clinical Perspective. Int J Cardiovasc Imaging. 2017; 33(7): 961-974.
  8. De Bruyne, B. et al. FFR Guided PCI versus Medical Therapy in Stable Coronary Disease. N Engl J Med. 2012; 367 (11): 991-1001.
  9. PressureWire™ X Guidewire Instructions for Use (IFU). Refer to IFU for additional information. 
  10. CoroFlow‡ Cardiovascular System Instructions for Use (IFU). Refer to IFU for additional information.
  11. Zimmermann FM, et al. 2015: Deferral vs. performance of percutaneous coronary intervention of functionally non-significant coronary stenosis: 15-year follow-up of the DEFER trial. Eur Heart J. 2015;36(45):3182-3188. doi:10.1093/eurheartj/ehv452.
  12. Smits PC, Abdel-Wahab M, Neumann FJ, et al, on behalf of the Compare-Acute Investigators. Fractional flow reserve–guided multivessel angioplasty in myocardial infarction. N Engl J Med. 2017;376:1234-1244.
  13. Bech GJW, et al. Fractional flow reserve to determine the appropriateness of angioplasty in moderate coronary stenosis: a randomized trial. Circulation. 2001;103:2928-2934.
  14. Tonino PA, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-224.
  15. Wijns W, et al. Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2010;31(20):2501-2555.
  16. Curzen N, et al. Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain: the RIPCORD study. Circ Cardiovasc Interv. 2014;7(2):248-255.
  17. Van Belle E, et al. Outcome impact of coronary revascularization strategy reclassification with fractional flow reserve at time of diagnostic angiography: insights from a large French multicenter fractional flow reserve registry. Circulation. 2014;129(2):173-185.
  18. Baptista S, et al. Impact of Routine Fractional Flow Reserve Evaluation During Coronary Angiography on Management Strategy and Clinical Outcome. One-year results of the POST-IT Multicenter Registry. Circ Cardiovasc Interv. 2016;9:e003288.
  19. Layland J, et al. Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS–NSTEMI randomized trial. Eur Heart J. 2015;36(2):100-111.
  20. Engstrøm T, et al. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3—PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015;386(9994):665-671.
  21. Nishi T, et al. Influence of contrast media dose and osmolality on the diagnostic performance of contrast fractional flow reserve. Circ Cardiovasc Interv. 2017;10:e004985.
  22. Van Belle E, et al. Impact of routine fractional flow reserve on management decision and 1-year clinical outcome of patients with acute coronary syndromes: PRIME-FFR (insights from the POST-IT [POrtuguese Study on The Evaluation of FFR-guIded Treatment of coronary disease] and R3F [French FFR Registry] Integrated MulticEnter registries - implementation of FFR [fractional flow reserve] in routine practice). Circ Cardiovasc Interv. 2017;10:e004296.
  23. Fearon WF, et al. Clinical outcomes and cost-effectiveness of fractional flow reserve–guided percutaneous coronary intervention in patients with stable coronary artery disease: three-year follow-up of the FAME 2 Trial. Circulation. 2018;137:480-487.
  24. 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.
  25. Toth GG, De Bruyne B, Kala P, et al. Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting: the GRAFFITI trial. EuroIntervention. 2019;15(11):e999-e1005.
  26. Ramos R, Batista S, Raposo L, et al. Strategies for revascularization in patients undergoing heart valve surgery with concomitant coronary artery disease (SAVE-IT). Website accessed on 9/20/2022: https://clinicaltrials.gov/ct2/show/NCT02173860.
  27. Puymirat E, et al. FLOW Evaluation to guide Revascularization in multi-vessel ST-elevation Myocardial Infarction (FLOWER-MI). Website accessed on 9/20/2022: https://clinicaltrials.gov/ct2/show/NCT02943954.
  28. Bohm F, et al. Ffr-gUidance for compLete Non-cuLprit REVASCularization (FULL REVASC). Website accessed on 9/20/2022: https://clinicaltrials.gov/ct2/show/NCT02862119.
  29. Schampaert E, Kumar G, Achenbach S, et al. A global registry of fractional flow reserve (FFR)-guided management during routine care: study design, baseline characteristics and outcomes of invasive management. Catheter Cardiovasc Interv. Published online ahead of print, March 14, 2020.
  30. Pijls NHJ, et al. A comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease (FAME 3). NCT02100722. Website accessed on 9/22/2022: https://clinicaltrials.gov/ct2/show/NCT02100722

MAT-2208166 v1.0

Important Safety Information

Coroventis‡ CoroFlow‡ Cardiovascular System

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Indications: CoroFlow‡ is indicated to provide hemodynamic information for use in the diagnosis of patients with cardiovascular diseases.

CoroFlow‡ 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 measuring devices.

Contraindications: The system has no patient alarm functions. Do not use for cardiac/vital signs monitoring.

Warnings:

  • If CoroFlow‡ is used together with 3rd party infusion catheters for assessment of Absolute Flow and Resistance, ensure that the maximum infusion rate per manufacturers instruction is not exceeded or vessel injury may occur.
  • Do not use the CoroFlow‡ measurement system if there is reason to believe the system's security has been compromised or if the system was unaccounted for a period of time (i.e. misappropriated, modified or tampered with).
  • Do not leave the CoroFlow‡ measurement system unattended when logged in as a PC Administrator
  • To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access-controlled environment.
  • To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), the PC on to which CoroFlow‡ is installed must be configured according to the Installation Instructions in this manual. Failure to configure the PC correctly may result in increased risk for unauthorized release of protected health information. Windows settings include:
    • Activation and configuration of restricted user Access
    • Activation of Windows Firewall and blocking of network connections
    • Activation of Windows Bitlocker drive encryption
    • Activation of Windows Secure Boot
    • Activation of Windows Anti-Virus scanning
    • Activation of Windows update
  • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
  • Use of accessories, transducers and cables other than those specified or provided by Coroventis‡ could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of CoroFlow‡, including cables specified by Coroventis‡. Otherwise, degradation of the performance of this equipment could result.

 

Precautions:

  • The PC and CoroHub‡ shall not be placed within the patient environment (1.5 m from patient).
  • For operation of other devices used in conjunction with CoroFlow‡ consult the IFU for each of these devices for details on indication, handling and safety information.
  • It is recommended to ensure local routines for data backup of stored recordings. CoroFlow‡ does not create backup of stored data.
  • Always check minimum performance requirement on PC to ensure compatibility with CoroFlow‡.
  • It is recommended to install CoroFlow‡ on a PC with backup battery to avoid interruption in case of power failure.
  • Always manually review and confirm valid cursor positions and detected heart beats.
  • Ensure that Pa and Pd pressure waveforms are aligned in phase and offset after equalization, or indices can be mis-calculated.
  • Confirm that the correct Wi-Box is selected by manually matching the Wi-Box ID number with the Wi-Box in the lab.
  • Changing parameter settings outside of default values may affect measurement performance, only for research purposes.
  • Only to be used by healthcare professionals
  • Using a network location to store data may cause previously unidentified risks if the network malfunctions
  • The assembly of medical electrical systems and modifications during the actual service life require evaluation to the requirements according to IEC 60601-1 standard series.
  • CoroHub‡ does not have any serviceable parts and require no field maintenance. No modification or tampering with CoroHub‡ is permitted.
  • CoroHub‡ shall not be immersed in liquid.
  • CoroHub‡ shall not be used if it has been subject to damage
  • Direct connection to a non-secure network, like the internet, may interfere with correct operation and/or result in inappropriate access to patient information. Furthermore, it should be noted that reconfiguring a used network may lead to inability to import patient as well as export examination data, ultimately leading to a risk of loss of patient and examination data. To avoid this problem Coroventis‡ recommends verifying network settings in the system setup after each change.

MAT-2007904 v3.0

Ultiri™ Measurement System

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Indications:

The Ultiri™ Measurement System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise, and clinical judgment, to determine if therapeutic intervention is indicated.

Contraindications:

There are no known contraindications for the Ultiri™ Measurement System.

Warnings:

  • No modification of this equipment is allowed.
  • Prior to use, please review the installed software User Manual and the Instructions for Use supplied with the Ultiri™ Measurement System, Wi-Box™ AO Transmitter, and the PressureWire™ X Guidewire for more information on warnings, precautions / cautions, and set-up instructions.
  • Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
  • The operator should not touch Ultiri™ Measurement System non-CF connectors (or other non-medical equipment) and the patient or patient leads at the same time. Conductive connection may cause leakage currents to induce ventricular fibrillation.
  • High frequency surgical equipment must not be used on a patient at the same time as the PressureWire™ X Guidewire and the Ultiri™ Measurement System.
  • Do not use this device for any conditions contraindicated for use of compatible guide wires.
  • Inside the catheterization laboratory only port-powered USB drives may be connected to the USB port. Connecting externally powered devices to the USB port in the patient vicinity may compromise electrical isolation and cause patient injury.
  • External equipment intended for connection to signal output or other connectors shall comply with relevant IEC standard (e.g., IEC 60601 series for medical electrical equipment). In addition, all such combinations of systems shall comply with the standard IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Any person who connects external equipment to signal output, or other connectors, has formed a system and is therefore responsible for compliance of the system with the requirements of IEC 60601-1. If in doubt contact a qualified technician. Only the PressureWire™ X Guidewire and the Wi-Box™ AO Transmitter are intended to be used with the Ultiri™ Measurement System wireless receivers.
  • Connecting to External Equipment - When used in the patient environment, all equipment connected to the Ultiri™ Measurement System must meet the requirements for medical isolation according to the IEC 60601 safety standards. Connection of equipment that does not follow relevant IEC standards (e.g., IEC 60601 series for medical electrical equipment) may lead to patient injury or death.
  • The HDMI output is not isolated. External equipment which is connected to this output must provide isolation against leakage current. The user is responsible for compliance with the requirements of standard IEC 60601- 1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
  • Electrical Shock Hazard - Do not remove Ultiri™ Measurement System covers. To avoid electrical shock, use only the power supply and power cord supplied with the system. Refer to “Setting Up the System” and “Safety Information” for electrical safety information.
  • The main power remains switched on when the system is in Standby mode. Avoid direct or indirect (e.g., via the operator) conductive connection between other electrical equipment and the Ultiri™ Measurement System. Conductive connection may cause leakage currents to induce ventricular fibrillation. High frequency surgical equipment must not be used on a patient at the same time as PressureWire™ X Guidewire and the Ultiri™ Measurement System.
  • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the Ultiri™ Measurement System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Do not use the Ultiri™ Measurement System if it has been dropped, or in any other way exposed to mechanical or electrical damage, or if liquids are suspected to have penetrated the casing or the power supply unit. This can cause the user to be exposed to electric shock or loss of system function. Contact Abbott Technical Service for further instructions.
  • Do not sterilize the Ultiri™ Measurement System or any of its parts. Do not use this system or any of its parts if it has been sterilized.
  • The Ultiri™ Measurement System contains a lithium battery for the system real-time clock. Danger of explosion. Battery is not intended to be replaced.
  • To prevent possible patient or operator injury and damage to the system, make sure the equipment is securely mounted.
  • Make sure the unit is dry before connecting it to the power supply.
  • The PressureWire™ X Guidewire is sterilized by ethylene oxide and is intended for one-time use only. Nonpyrogenic. Do not use if the package is opened or damaged. Do not reuse or re-sterilize. Any attempt to reuse or re-sterilize the PressureWire™ X Guidewire may compromise the structural integrity of this device. Adverse effects of using a non-sterile or re-sterilized guide wire may include, but are not limited to: local and / or systemic infection, mechanical damage, inaccurate results.
  • Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. If abnormal performance is observed, it is necessary to increase distance between equipment.
  • To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access-controlled environment. Do not use the Ultiri™ Measurement System if there is reason to believe the system’s security has been compromised or if the system was unaccounted for during a period of time (i.e., misappropriated, modified, or tampered with).
  • The system has no patient alarm functions. Do not use for cardiac monitoring.

 

Precautions:

  • Patients with potential microvascular dysfunction and borderline index values should be interpreted with caution, and management strategies should be guided not only by pressure measurement, but also by possible supplementary clinical risk stratification and other tests.
  • Before performing a physiological parameter procedure or creating a physiological parameter recording, review the installed software User Manual for additional warnings and cautions.
  • To connect to the correct Wi-Box™ AO Transmitter, you must select the room where the system is being used. The first time you connect to a room, you must enter the room’s information into the system. Refer to the installed software User Manual for more information.
  • Do not unplug from AC power or turn off main power until the shutdown is complete and the screen turns black. Disconnecting from AC power before the shutdown is complete may damage the system.
  • The power switch shuts down the Ultiri™ Measurement System, but power remains in the mains cable and power supply unit. To fully disconnect from mains power, remove the mains power plug from the wall socket.
  • Output sensitivity changes should be performed by a qualified technician. Incorrect settings may result in discrepancies between monitor system and Ultiri™ Measurement System values.
  • Direct connection to a non-secure network (e.g., the internet) may interfere with correct operation and / or result in inappropriate access to patient information. Furthermore, it should be noted that reconfiguring a used network may lead to inability to import or export patient examination data, ultimately leading to a risk of loss of patient and examination data. To avoid this problem, Abbott Technical Service recommends verifying network settings in the system setup after each change.
  • No connections to other systems or components are to be made to the Ultiri™ Measurement System except through the Connector Panel. No connections are to be made through the Connector Panel except as described in this manual. In addition, all such combinations of systems shall comply with the standard IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Any person who connects external equipment to the Ultiri™ Measurement System has formed a medical system and is therefore responsible for compliance of the system with the requirements of IEC 60601-1. If in doubt contact a qualified technician. Only the PressureWire™ X Guidewire and the Wi-Box™ AO Transmitter are intended to be used with the Ultiri™ Measurement System.
  • PressureWire™ X Guidewire readings may be affected by defibrillation. After defibrillation, restart the procedure. Re-zero and re-equalize the PressureWire™ X Guidewire.
  • Radio transmitting equipment, cellular phones, and strong emission sources such as high frequency surgical equipment shall not be used in close proximity to the Ultiri™ Measurement System since this could influence the performance of the device.

    Note: The device should be used in a hospital environment except for near active high frequency (HF) surgical equipment and the radio frequency (RF) shielded room of a medical equipment system for magnetic resonance imaging, where the intensity of electromagnetic (EM) disturbances is high.
  • Check that the monitor cables and aortic pressure transducer (AO) adapter delivered with the Ultiri™ Measurement System interface are compatible with the catheterization laboratory system to be used. The AO should be in accordance with ANSI / AAMI BP22-1994. After the laboratory monitor system has been zeroed, use only the Ultiri™ Measurement System to calibrate the AO and PressureWire™ X Guidewire.
  • After use, the PressureWire™ X Guidewire may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
  • Do not immerse in liquid: Do not use the Ultiri™ Measurement System if it has been immersed in liquid.
  • Ensure that all ventilation holes are unblocked to avoid system overheating and false readings.

 

Potential Adverse Events:

Potential complications which may be encountered during all catheterization procedures include, but are not limited to:

  • Angina
  • Arrhythmia
  • Bleeding
  • Coronary vascular injury
  • Death
  • Drug reactions to vasodilators (e.g., Adenosine or nitroglycerine) used to induce hyperemia during FFR determination such as bronchospasm, dyspnea, bradycardia, coronary artery spasm
  • Hypotension
  • Infection
  • Ischemia
  • Potential allergic reactions to drugs administered for the procedure
  • Stenosis

MAT-2208955 v2.0

MAT-2208955 v2.0

PressureWire™ X Guidewire

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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 in FFR procedures.
    • 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 (15°C – 25°C) 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.

In addition, this device has a coating containing Polyethylene Glycol (PEG); potential allergic reactions (anaphylaxis) may occur during the interventional procedure if the patient is allergic to PEG.

MAT-2103599 v2.0

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HEALTHCARE PROFESSIONALS
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CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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MAT-2001111 v7.0

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MAT-2305078 v1.0