Coronary Physiology Products

Go Beyond the Angiogram with Abbott's Coronary Physiology Portfolio

Physiological measurements such as fractional flow reserve (FFR) and resting full-cycle ratio (RFR) can be used to evaluate the functional significance of coronary stenosis. ^1,2

Beyond the visibility of angiography, index of microcirculatory resistance (IMR) and coronary flow reserve (CFR) can be used to diagnose coronary microvascular dysfunction.^3,4

A comprehensive physiology assessment can improve PCI outcomes and patients quality of life.^{3, 5-6}

PressureWire™ X Guidewire

The innovative PressureWire™ X Guidewire—the world’s only wireless physiology wire^1,3,7—can measure pressure and temperature to calculate Abbott's RFR, FFR, IMR, and CFR. The guidewire’s fully integrated, secure, wireless measurements are integral to a cardiac cath lab’s clinical physiology routine.¹

View Product

Coroventis^‡ CoroFlow^‡ Cardiovascular System

Used with the PressureWire™ X Guidewire, the Coroventis^‡ CoroFlow^‡ Cardiovascular System is an advanced platform to measure comprehensive physiological indices: FFR, RFR, IMR, and CFR.⁸

View Product

QUANTIEN™ Measurement System

The QUANTIEN™ Measurement System, with its wireless design, frees the cardiac cath lab from cables. The QUANTIEN™ Measurement System offers users full integration without time-consuming setup or lab downtime.⁹

View Product

OPTIS™ Imaging Systems

The OPTIS™ Imaging Systems offers wireless physiology (FFR and RFR) and optical coherence tomography (OCT) with seamless integration into the cath lab and PCI workflow.¹⁰

View Product

ULTREON™ 1.0 Software

Ultreon™ 1.0 Software is the next-generation imaging and physiology software. Streamlined and intuitive, Ultreon™ Software gives better insights to optimize patient outcomes through automation and improved workflow.^11-14

View Product

Abbott's Legacy of Leadership in Coronary Physiology

As a leader in PCI, Abbott also has a rich legacy of supporting research, developing products and advancing technology related to coronary physiology. Abbott’s accomplishments offer interventional cardiologists key data as well as cutting-edge technology.

Manuals & Resources

Customer Service

References

PressureWire™ X IFU
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.
Ford T, et al. CorMicA Trial. 2018; 72(23): 2841-55 with online appendix.
Kunadian V, Chieffo A et al. EHJ & Eurointervention 2020: ehaa503. DOI:10.1093/eurheartj/ehaa503.
Tonino PA, et al. Angiographics versus functional severity of coronary artery stenoses in the FAME study: Fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol 2010; 55:2816-21.
De Bruyne B, et al. FFR Guided PCI versus Medical Therapy in Stable Coronary Disease, NEJM. 2012; 367 (11): 991-1001.
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.
Coroventis^‡ CoroFlow^‡ Cardiovascular System IFU.
QUANTIEN™ Measurement System IFU.
OPTIS™ Measurement System IFU
Data on file at Abbott.
Zhang J, et al. Intravascular ultrasound versus angiography-guided drug-eluting stent implantation: the ULTIMATE trial. J Am Coll Cardiol. 2018;72(24):3126-3137. doi: 10.1016/j.jacc.2018.09.013.
Hong M, et al. IVUS-XPL 5 Year Outcomes, TCT 2019.
Jones et al. JACC Cardiovascular Interventions, 2018, vol 11 (14). “Angiography Alone Versus Angiography Plus Optical Coherence Tomography to Guide Percutaneous Coronary Intervention – Outcomes From the Pan-London PCI Cohort”.

MAT-2201011 v1.0

IMPORTANT SAFETY INFORMATION

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 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

Coroventis^‡ CoroFlow^‡ Cardiovascular System

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

QUANTIEN™ Measurement System

Indications: The QUANTIEN™ Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.

The QUANTIEN™ Measurement 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 it for cardiac monitoring.

Warnings:

No modification of this equipment is allowed.
Do not open or remove access covers on the QUANTIEN™ Measurement System unless specifically instructed by technical support to do so.
External equipment intended for connection to signal input, 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 60601-1-1, Safety requirements for medical electrical systems, alternatively IEC 60601-1 ed.3 §16, ME SYSTEMS. 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 these requirements. If in doubt, contact a qualified technician, or alternatively, your representative or technical support.
Do not use the QUANTIEN™ Measurement System if it has been dropped or in any other way exposed to mechanical or electrical damage. This can cause the user or patient to be exposed to electric shock or cause faulty readings of data. Contact your representative or technical support for further instructions.
Do not use the QUANTIEN™ 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).
High frequency surgical equipment must not be used on a patient at the same time as PressureWire™ Guidewire and the QUANTIEN™ Measurement System.
Do not use the QUANTIEN™ Measurement System if liquid is suspected to have penetrated the enclosure or the power supply unit. This can cause the user or patient to be exposed to electric shock. Contact your representative or technical support for further instructions.
Do not sterilize the QUANTIEN™ Measurement System or any of its parts. Do not use this system or any of its parts if it has been sterilized.
The QUANTIEN™ Measurement System contains a lithium battery for the system real-time clock. Danger of explosion. Battery is not intended to be replaced.
Do not leave the QUANTIEN™ Measurement System unattended when logged in as a Site 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.

Precautions:

The QUANTIEN™ Measurement System is Type CF equipment and protected against the effects of a discharge of a defibrillator. PressureWire™ Guidewire readings may be affected by defibrillation. After defibrillation restart procedure, i.e. re-zero and re-equalize PressureWire™ Guidewire.
If it is necessary to install the QUANTIEN™ Measurement System adjacent to other equipment, this system should be observed to verify normal operation. If abnormal performance is observed, it is necessary to increase distance between equipment.

MAT-2202673 v1.0

OPTIS™ Imaging Systems and Software

Indications The OPTIS™ Software and AptiVue™ E Series Software are intended to be used only with compatible OPTIS™ Imaging Systems.

The OPTIS™ Imaging System with a compatible Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly™ Imaging Catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ Imaging Catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS™ Imaging 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: The OPTIS™ Integrated System and Mobile System with Software are contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:

Bacteremia or sepsis
Major coagulation system abnormalities
Patients diagnosed with coronary artery spasm
Patients disqualified for CABG surgery
Patients disqualified for PTCA
Severe hemodynamic instability or shock
Total occlusion
Large thrombus
Acute renal failure

NOTE: The systems have no patient alarm functions. Do not use for cardiac monitoring.

Warnings:

Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
Observe all advancement and movement of the Dragonfly™ Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage.
Leave the guidewire engaged with the catheter at all times during use. Do not withdraw or advance the guidewire prior to withdrawing the catheter.
If resistance is encountered during advancement or withdrawal of the Dragonfly™ Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter and guidewire together.
The Dragonfly™ Imaging Catheter should never be forced into lumens that are narrower than the catheter body or forced through a tight or heavily calcified lesion.
The Dragonfly™ Imaging Catheter should not be advanced through abnormally tortuous anatomy.
When advancing or retracting a catheter with a monorail tip through a stented vessel, the catheter may engage the stent between the junction of the Dragonfly™ Imaging Catheter and guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.
Refer to the contrast media’s instructions-for-use for general warnings and precautions relating to use of the contrast media.
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 OPTIS™ Imaging 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).

Precautions:

Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
For optimal imaging, only use 100% contrast media.
Store the Dragonfly™ Imaging Catheter at ambient temperature in a dry location out of direct sunlight.
Never attempt to attach or detach a Dragonfly™ Imaging Catheter to the DOC while the “lock” LED is lit.
Do not kink, sharply bend, pinch, or crush the Dragonfly™ Imaging Catheter at any time.
The Dragonfly™ Imaging Catheter is for single use only. Do not reuse, re-sterilize, or reprocess.
The Dragonfly™ Imaging Catheter is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged.
After use, the Dragonfly™ Imaging Catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
The Dragonfly™ Imaging Catheter has no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.

MAT-2115909 v2.0

OPTIS™ Next Imaging Systems and Software

Indications

The Ultreon™ 1.0 Software is intended to be used only with compatible OPTIS™ Next Imaging Systems. The OPTIS™ Next Imaging System with a compatible Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ OPTIS™ Imaging Catheter or Dragonfly OpStar™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS™ Next Imaging 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: Use of the Ultreon™ 1.0 Software is contraindicated where introduction of any catheter would constitute a threat to patient safety.
Contraindications include:

Bacteremia or sepsis
Major coagulation system abnormalities
Patients diagnosed with coronary artery spasm
Patients disqualified for coronary artery bypass graft (CABG) surgery
Patients disqualified for percutaneous transluminal coronary angioplasty (PTCA)
Severe hemodynamic instability or shock
Total occlusion
Large thrombus
Acute renal failure
Inability to tolerate systemic anticoagulation is a contraindication to use of OCT for coronary imaging.
PressureWire™ Guidewire is contraindicated for use in the cerebral vasculature.
The system has no patient alarm functions. Do not use for cardiac monitoring.

Complications: The risks involved in vascular imaging include those associated with all catheterization procedures. The following complications may occur as a consequence of intravascular imaging and may necessitate additional medical treatment including surgical intervention.

Abnormal heart rhythm or arrhythmias
Acute myocardial infarction
Allergic reaction to the contrast media or drug administered for the procedure
Arterial dissection, injury, or perforation
Bleeding
Catheter access site reactions: sterile inflammation or granuloma
Coronary artery spasm
Death
Embolism
Myocardial ischemia
Renal insufficiency or failure from contrast media use
Repeat revascularization
Thrombus formation, abrupt closure, or total occlusion
Tissue necrosis
Unstable angina
Hypotension

Warnings:

Refer to the contrast media Instructions for Use for general warnings and precautions relating to use of contrast media.
The heart rate and mean pressure values shown on the OPTIS™ Next Imaging System are for reference only and are not intended to be used as the primary display.
The system may place the point of index value at the wrong location due to pressure artifacts, for example: abnormal heartbeats, artifacts in AO (Pa) caused by flushing of guiding catheter, or valve opening / closing. The physician should always confirm that the point selected by the system is a valid point for the calculation of index value.
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.
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 OPTIS™ Next Imaging 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).

Precautions:

Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
Monitor the OCT image for indications of Dragonfly™ Imaging Catheter optical failure. If optical failure is suspected, remove the Dragonfly™ Imaging Catheter from the patient, press “Unload” on the drive motor and optical controller (DOC), detach the catheter, and replace it with a new one.
If the pullback triggers before contrast is injected, repeat the pullback.
For optimal imaging, only use 100% contrast media.

MAT-2104193 v3.0

CARDIOVASCULAR

Coronary Physiology Products

Go Beyond the Angiogram with Abbott's Coronary Physiology Portfolio

PressureWire™ X Guidewire

Coroventis^‡ CoroFlow^‡ Cardiovascular System

QUANTIEN™ Measurement System

OPTIS™ Imaging Systems

ULTREON™ 1.0 Software

Abbott's Legacy of Leadership in Coronary Physiology

References

IMPORTANT SAFETY INFORMATION

PressureWire™ X Guidewire

Coroventis^‡ CoroFlow^‡ Cardiovascular System

QUANTIEN™ Measurement System

OPTIS™ Imaging Systems and Software

OPTIS™ Next Imaging Systems and Software

Indications

POLICIES & ADVISORIES

HEALTHCARE PROFESSIONALS

PATIENTS & CAREGIVERS

CARDIOVASCULAR

Coronary Physiology Products

Go Beyond the Angiogram with Abbott's Coronary Physiology Portfolio

PressureWire™ X Guidewire

Coroventis‡ CoroFlow‡ Cardiovascular System

QUANTIEN™ Measurement System

OPTIS™ Imaging Systems

ULTREON™ 1.0 Software

Abbott's Legacy of Leadership in Coronary Physiology

References

IMPORTANT SAFETY INFORMATION

PressureWire™ X Guidewire

Coroventis‡ CoroFlow‡ Cardiovascular System

QUANTIEN™ Measurement System

OPTIS™ Imaging Systems and Software

OPTIS™ Next Imaging Systems and Software

Indications

POLICIES & ADVISORIES

HEALTHCARE PROFESSIONALS

PATIENTS & CAREGIVERS

Stay Connected

Coroventis^‡ CoroFlow^‡ Cardiovascular System

Coroventis^‡ CoroFlow^‡ Cardiovascular System