The CoroFlow‡ Cardiovascular System is an advanced platform to measure physiological indices: fractional flow reserve (FFR) and resting full-cycle ratio (RFR) to assess epicardial vessels; plus coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) to assess the microcirculation. This system is designed specifically to communicate with the wireless PressureWire™ X Guidewire.
The CoroFlow‡ Cardiovascular System is capable of calculating and displaying hemodynamic measurements in both epicardial vessels and coronary microvasculature. Moreover, 50-65% of patients with angina with non-obstructive coronary artery disease (NOCAD) are believed to have Coronary Microvascular Dysfunction (CMD).3 A clear diagnosis of CMD for persistent angina patients can improve their quality of life.1
CoroFlow‡ Cardiovascular System provides physiology data for vessel characteristics throughout the entire coronary vasculature.
CoroFlow Cardiovascular System Instructions For Use (IFU). Refer to IFU for additional information.
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*with IMR, CFR, RFR and FFR
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.