CATH CMD is a global algorithm that captures the essential details of performing the bolus thermodilution workflow and assists in decision-making in a simple and stepwise manner. In summary, CATH captures the how to perform bolus thermodilution and CMD captures the what to do with the Coronary Flow Reserve (CFR) and Index of Microcirculatory Resistance (IMR) measurements to provide a diagnosis of Coronary Microvascular Dysfunction (CMD).
A comprehensive physiology assessment (with Resting full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), IMR and CFR) of the epicardial arteries and the microvasculature can provide patients with persistent angina an accurate diagnosis to improve outcomes.1
*Repeat measurement of Tmnrest
*Decrease in pressure, patient symptoms, FFR drop
**Repeat measurement of Tmnhyp
*Evolving concensus
*Evolving consensus
GTN (glyceryl trinitrate) | NTG (nitroglycerin) | LAD (left anterior descending) | FFR (fractional flow reserve) | IMRcorr (IMR corrected) | CMD (coronary microvascular dysfunction) | Tmnrest (resting transit mean time) | Tmnhyp (hyperemic transit mean time)
MAT-2302515 v1.0
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:
Precautions:
MAT-2007904 v3.0
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:
Precautions:
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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