ACIST RXI - 1 Introduction; Indications for Use;Intended Use; Intended Patient Population; Device Description

ACIST RXi System User’s Guide | 1901700-001,01 2019-09 English
Indications for Use/Intended Use
1 Introduction
e ACIST RXi® System is indicated for obtaining intravascular pressure
measurements for use in the diagnosis and treatment of coronary and
peripheral artery disease. e ACIST Navvus® MicroCatheter is intended for
use with the ACIST RXi System.
Note
The RXi System is for use only on the order of a physician by medical professionals with
adequate training and experience in the operation of the RXi System and angiographic
procedures and techniques. Additionally, individuals using this device must be alert and
attentive to the operation of the system while it is connected to the patient catheter.
Diligence on the part of the user is an essential requirement of overall device safety.
is product is designed for use in adult patients identied by a physician
as suitable candidates for vascular pressure measurement, taking into
consideration the patient's anatomy and health status.
e ACIST RXi System is designed to provide hemodynamic information
for the diagnosis and treatment of coronary and peripheral artery disease.
e system is intended for use in catheterization and related cardiovascular
specialty laboratories to compute and display fractional ow reserve (FFR) and
resting Pd/Pa.
FFR and resting Pd/Pa supplements the visual data provided by angiography
and provides an assessment of the lesion severity.
Measurement of FFR and resting Pd/Pa requires simultaneously monitoring
the blood pressures proximal and distal to a lesion. e ACIST RXi System
includes a single-use microcatheter with a pressure sensor for acquisition of
the distal pressure. e proximal pressure is acquired via the guide catheter
which is monitored by the ACIST RXi System via an interface to the hospital’s
hemodynamic monitor.
Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressure,
measured at resting conditions. e physician may then use the resting Pd/
Pa value, along with knowledge of patient history, medical expertise and
Indications for
Use/Intended
Use
Intended Patient
Population
Device
Description