Computer, cardiac catheterization laboratory

Intended purpose

The Rapid Exchange (RXi) System is a hardware system containing embedded software, a user interface touchscreen, and electronics. The Rapid Exchange System provides hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve or FFR. FFR is typically used to determine when treatment of a vessel lesion is needed and measurement of FFR requires simultaneously monitoring the blood pressures proximal and distal to a lesion. The RXi System is available in one (1) configuration: Model Number 014666 The Intended Use/Indication for Use of the Rapid Exchange (RXi) System is as follows: The ACIST Rapid Exchange (RXi) System is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease.