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The Shadow Catheter™ is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.

The Shadow Guidewire Positioning Catheter is a dual lumen over-the-wire catheter, compatible with a 6F or larger guiding catheter and 0.014" guidewires. The Catheter is designed to support and aim steerable guidewires. The Catheter consists of a distal tip with markers, torque shaft and guidewire introducer. The distal end of the Catheter (the nosecone) has two ports, one to load a tracking guidewire axially (via distal port) and the other for the positioning guidewire to exit radially (via side port). The distal nosecone is coated with a hydrophilic coating. The Shadow Catheter™ has three markers in the nosecone. The guidewire introducer accommodates an on-axis tracking guidewire, a tracking guidewire flush port, as well as a positioning guidewire introducer port that doubles as a flush port. The handle may be rotated or orientated to adjust or aim the direction of the positioning guidewire exiting the side port at the distal end. The Catheter is placed in a packaging hoop, sealed in a Tyvek® pouch, and packaged in a shelf carton. There are no diagnostic or therapeutic agents known to be incompatible with the Shadow Catheter™. The Shadow Catheter™ is sterilized with ethylene oxide.