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The Dispatch Gold Coronary Infusion Catheter is intended for controlled and selective infusion of solution(s), including thrombolytic agents, into the vessel.

The Dispatch Gold Coronary Infusion Catheter is a non-dilatation, over-the-wire device designed for localized delivery of solution(s), through the openings located in the distal segment, into the selected coronary artery. The device has a single lumen shaft with a distally located inflation coil 20 mm, 30 mm or 50 mm in length. The number of coils increases with length. The inflation coil, encapsulated by a thin polyurethane sheath, may be inflated to further localize or isolate delivery to subselected vasculature. The lumen of the shaft is used to transport solutions, as well as to house an inner tube and inflation tube running the length of the shaft and situated concentrically within the lumen. The inner tube permits the use of coronary guide wires < 0.014" to advance the device through the anatomy to the intended infusion site. The distal tip is tapered to facilitate the advancement of the device through the vasculature. Radiopaque markers are located at both the proximal and distal ends of the balloon coil to assist in the placement of the device's distal assembly. Shaft locating markers are printed proximally on the outer shaft of the catheter to ensure proper placement of the distal infusion segment with respect to the guide catheter. One marker is designated by two parallel white stripes located at 100 cm and the other is designated by a single white stripe located at 90 cm from the distal tip for femoral and brachial approaches respectively. The proximal portion of the device consists of a manifold with a blue inflation port and a yellow infusion port. The inner lumen is connected to an unmarked thru port for guide wire insertion, which also has a luer lock fitting for the connection of a Y-adapter if desired.

This document describes a medical device, the SCIMED Dispatch Gold Coronary Infusion Catheter, and its comparison to existing predicate devices. It largely focuses on technical specifications and non-clinical testing to establish substantial equivalence.

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