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The AC3™ Range ™ Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions: - 1. Acute Coronary Syndrome - 2. Cardiac and Non-Cardiac Surgery - 3. Complications of Heart Failure

The AC3 Range IABP system is a professional use device that provides counter-pulsation therapy to adult patients with impaired Left Ventricular (LV) Function. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. The AC3 Range IABP system consists of two (2) components: (1) the pump control/display module which incorporates a display, touch screen, and keypad for system operation and (2) the pneumatic drive module with attached wheels for easy transport. The IABP is attached to an intra-aortic balloon (IAB) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta. The pump display incorporates a high-definition touchscreen with color coded icons and a keypad for system operation. The AC3 Range IABP uses software to select and maintain precise IAB catheter inflation timing and triggering based on real time physiological data from the patient. The system offers two modes of operation, (1) the AutoPilot mode, where most functions are automatically selected and controlled by IABP and (2) the Operator mode where the user has control over most settings and selections.

The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

The Arrow Pressure Injectable Midline Catheter is a non-coated, single use catheter designed to provide short-term peripheral access to the venous system. The midline catheter is a peripherally inserted intravenous catheter manufactured with medical grade, flexible polyurethane. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a single opening or double opening at the distal end and centimeter markings placed along its length to facilitate its positioning. The catheter is available in 4 Fr. Single lumen and 5 Fr. Double lumen configurations with a usable catheter length of 20 cm. Pinch clamps are an integral part of the catheter and are provided on the extension lines to occlude flow through the lumens, as needed. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The catheters will be packaged sterile in kits that will include components to facilitate insertion.