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:
The benefits of using coronary physiology include:
With its pressure and temperature sensors, PressureWire™ X Guidewire has the capability to measure the entirety of the coronary circulation:9,10
PressureWire™ X Guidewire has been extensively studied and clinically validated in both stable and acute coronary syndrome (ACS) patients.5,11-12
PressureWire™ X Guidewire is the only9 wire with multiple connection options to eliminate clutter and meet your lab's needs.
Important Safety Information
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.
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.
There are no known contraindications for the Ultiri™ Measurement System.
Potential Adverse Events:
Potential complications which may be encountered during all catheterization procedures include, but are not limited to:
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.
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.
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