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The TriSalus TriGuide Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The TriSalus TriGuide is intended to be used in the peripheral vascular system.

The TriSalus TriGuideTM Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system. Its principle of operation is therefore to provide a patent pathway for compatible accessories as described within its labeling. TriSalus TriGuideTM Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The TriSalus TriGuide Catheter has a three-layer construction, consisting of a PTFE inner liner, stainless steel braid mid-layer, and an extruded Pebax polymer outer shaft jacket. The Pebax extruded polymer is filled with barium suffate (BaSO4) as a radiopacifier, to provide visibility of the TriSalus TriGuideTM Guiding Catheter under fluoroscopy. The TriSalus TriGuideTM Guiding Catheter are 65 cm in length in three pre-shaped tip designs including Axis, Sim 1, and Cobra to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic vessel tracking.

The TriSalus TriNav® LV Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The TriSalus® TriNav® LV Infusion System is a 0.025" lumen microcatheter, a self-expanding tip at the distal end. The TriNav® LV serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires with outer diameter up to 0.018" (0.46 mm), guiding catheters with inner diameter at least 0.048" (1.22 mm), embolic hydrogel particles 500 um or less in size and glass microspheres 110 um or less in size. The TriNav® LV has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, self-expanding tip is sized for use in vessels 3.0 mm to 5.0 mm in diameter. An optional, commercially available hemostasis valve (HV) is included. There are two radiopaque markers located at the distal end of the TriNav® LV device to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels. The TriSalus® TriNav® LV Infusion System is provided sterile (EtO) for single patient use.

The TriSalus Infusion System is intended for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The TriSalus Infusion System is a 0.021" lumen coaxial microcatheter with the Expandable Tip at the distal end. The TriSalus Infusion System serves as the conduit for physician-specified agents. The device has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The Expandable Tip and distal section (100 cm) of the microcatheter are hydrophilically coated. The soft, pliable, Expandable Tip is sized for use in vessels of 2 mm to 6 mm. There are four radiopaque markers located at the distal end of the TriSalus Infusion System to aid in positioning of Expandable Tip. The Expandable Tip can be expanded or collapsed up to 5 times for repositioning during an interventional procedure by moving the thumb-slide back and forth. When expanded, the Expandable Tip is designed to improve infusion efficiency of diagnostic and therapeutic agents. A commercially-available pressure transducer may be attached to the sideport luer connector if pressure measurement during infusion is desired. The system is provided sterile (EO) and for single patient use.