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JOVUS Eagle Eye™ F/X catheters are designed for use in the evaluation of vascular morphology blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. JOVUS Eagle Eye™ F/X ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The JOVUS Eagle Eye™ F/X catheters contain a catheter-tip ultrasound device that applies ultrasound energy dir ctly into the interior vessel wall of the patient to obtain an image of the vessel. This device is not currently indicated for use in cerebral vessels. The JOVUS Eagle Eye F/X catheter accommodates a 0.014" guide wire. The JOVUS Eagle Eye™ F/X catheter utilizes an integral guide wire lumen in which the catheter tracks over the guide wire at the distal tip. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The JOVUS Eagle Eye™ F/% catheter is introduced percutaneously or via surgical cutdown into the vascular sy:tem. A linear array ultrasonic transducer situated circumferentially near the tip of the catheter produces real time cross-sectional images of coronary and peripheral vessels. The JOVUS Eagle Eye™ F/X 2.9F catheters may only be used with the In-Vision™ Imaging System. This catheter will not operate if connected to any other imaging system.

In-Vision™ Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also incicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. ChromaFlo is indicated for qualitative blood flow information from peripheral and coronary vaculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

The JOMED Inc. In-Vision™ Imaging System consists of the imaging catheter, the patient interface module, and the system console. The system console gathers and displays high-resolution intra'uminal images that can be analyzed both qualitatively and quantitatively. In addition to supplying diagnostic information, the In-Vision™ Imaging Systems can be adjunct to interventional therapies, such as balloon angioplasty. With ChromoFloTM, a two-dimensional color map of relative blood flow is overlaid on the grayscale image, providing a ditional information for vessel analysis. The In-Line Digital™ option displays a two-dimensional, 360° rotations, and longitudinal view of the vessel.

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The JoWire Neo's Guide Wires are not to be used in the cerebral blood vessel.

The JoWire Asahi PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in a 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from stainless steel core wire with varying core lengths and diameters for each design. The core wire and core are soldered. The distal end of the guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic or silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The JoWire Neo's Guide Wires are not to be used in the cerebral blood vessel.

The JoWire Neo's PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in a 180 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire with varying core lengths and diameters for each design. The core wire and coil are soldered. The distal end of the wire guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic or silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.

The SmartWire/SmartMap Pressure System is intended for use in the coronary and peripheral arteries to measure blood pressure during diagnostic and/or interventional procedures. The SmartWire can also be used in replacement of an angioplasty guide wire to facilitate the placement of a balloon dilation catheter, as well as other interventional devices. Blood pressure measurements are obtained to provide hemodynamic information for the diagnosis and treatment of blood vessel disease. The SmartWire/SmartMap Pressure System is indicated for use in all blood vessels, I he Sinal White Smarthup Fressure Byoss to measures blood pressure during diagnostic angiography and/or interventional procedures.

The Jometrics SmartWire/SmartMap Pressure System consists of the SmartWire and the SmartMap. Additionally, the SmartWire can be used with the existing WaveMap with the inclusion of the Patient Cable Model 8000. The SmartWire is a steerable pressure monitoring guide wire used to obtain intracoronary pressure measurements before, during, and after interventional procedures. There are two lengths. 189 cm and 300 cm and the outside diameter is .014". The screw tip, core wire, proximal coil and hypotube are manufactured from stainless steel. The tip coil is composed of a platinum, iridium alloy and coated to provide lubricity. The hypotube and proximal coil are also coated to provide lubricity. The SmartMap is designed to interface a SmartWire Pressure Wire to the auxiliary input of hemodynamic (Physio Monitor) systems. The SmartMap's power is derived from the hemodynamic system and provides in return an industry standard (AAMI BP22-2-1994) 5uV/V/mmHg output back to the hemodynamic system. The instrument is intended to measure pressure from a pressure sensor on a guide wire in the coronary and peripheral vasculature during diagnostic and/or interventional procedures. The Patient Cable Model 8000 is a preamplifier/signal condition unit designed to interface the SmartWire family of wires to an existing WaveMap Instrument. It uses intelligence to set up the circuitry designed to process the SmartWire as done in the SmartMap so that SmartWires may be used with either the SmartMap or the WaveMap.