Indications For Use; Contraindications; Clinical Benefits - Abbott Ultiri 1015082 Operation Manual

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Ultiri™ Measurement System Operation Manual – 600327583 Rev. A

Indications for Use

The Ultiri™ Measurement System computes and displays various physiological
parameters based on the output from one or more electrodes, transducers, or
measuring devices.
The Ultiri Measurement System is compatible with the wireless PressureWire™ X
Guidewire.
The Ultreon™ Software is intended to be used only with the Ultiri Measurement
System.
CAUTION: The Ultiri Measurement System is intended for use by medical
personnel who are knowledgeable in physiological procedures. Abbott Medical
and its employees cannot give instructions in the interpretation or diagnosis of
recordings and makes no attempt to do so.
CAUTION: All operators must be knowledgeable in performing physiological
procedures prior to using the Ultiri Measurement System and the installed
software.

Contraindications

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

Clinical Benefits

• When integrated into coronary procedures, measurement of
physiological parameters such as Fractional Flow Reserve (FFR) has
been shown to reduce the incidence of major adverse coronary events
(MACE) in patients being treated for complex coronary artery disease
(CAD).
•
Measuring physiological parameters such as FFR allows more accurate
identification of hemodynamically relevant stenosis compared to use of
angiography alone.
•
Measuring physiological parameters such as FFR reduces mortality and
myocardial infarction compared to use of angiography alone.
• Use of physiological parameters such as FFR can facilitate clinical
decision-making regarding need for revascularization, particularly in
individuals without non-invasive stress test documentation of myocardial
ischemia.