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The infusion catheter is intended to assist in the controlled infusion of diagnostic or therapeutic solutions into the peripheral or coronary vasculature. The target vessel effective diameter is ≥ 2.0 mm. The catheter is placed by a physician using a guide catheter and over a guidewire that extends beyond the final position of the infusion catheter.

The TherOx® Infusion Catheter is a sterile, single-use, 4.6 French (F) intravascular catheter with a 127 cm usable length. The catheter is comprised of three sections; 1) a distal atraumatic soft tip 2) a semi-rigid but flexible shaft; and 3) a proximal luer hub for connection of solution-delivery devices. A radiopaque band at the distal tip allows fluoroscopic visualization of the catheter's location in the vessel.

TherOx Infusion Guidewires are intended for use in facilitating the placement of interventional devices in the cardiovascular and neurovascular system. TherOx Infusion Guidewires are designed for small vessel use. TherOx Infusion Guidewires are also intended to be used for the controlled selective infusion of physician-specified fluid agents before, during or after interventional procedures in the cardiovascular or neurovascular system. TherOx Infusion Guidewires are not intended for delivery of contrast agents. Fluid agents utilized with TherOx Infusion Guidewires should be fully prepared and used according to their manufacturer's instructions for use.

TherOx Infusion Guidewires are intended for use in facilitating the placement of interventional devices in the cardiovascular and neurovascular system. TherOx Infusion Guidewires are designed for small vessel use. TherOx Infusion Guidewires are also intended to be used for the controlled selective infusion of physician-specified fluid agents before, during or after interventional procedures in the cardiovascular or neurovascular system. TherOx Infusion Guidewires are not intended for delivery of contrast agents. Filuid agents utilized with TherOx Infusion Guidewires should be fully prepared and used according to their manufacturer's instructions for use. TherOx Infusion Guidewires are not intended for neonatal or pediatric use. The TherOx Infusion Guidewire has an outside diameter of .014 in. and is available 180 cm and 300 cm in length, and is intended to pass freely thru standard catheters that have a thru lumen of 016 in. or larger. The 300 cm TherOx Exchange Guidewire differs only in its overall length from the 180 cm TherOx Infusion Guidewire. The distal 180 cm of the TherOx Exchange Guidewire is identical to the 180 cm TherOx Infusion Guidewire. Only the proximal hypotube has been extended by 120 cm to achieve the 300 cm length. This extended proximal portion always remains outside the body and facilitates the replacement of one interventional device for another. A proximal fluid connection is secured by connecting the proximal open end to a simple Tuohy-Borst connection. The infusion guidewire may be torqued by rotation of the torquing knob to direct the orientation of the distal tip.