Search Results

ComboWire™ and ComboTip™ Pressure/Flow Guide Wire is indicated for use to measure simultaneous pressure and blood flow velocities in blood vessels, including coronary and peripheral vessels, during diagnostic angiography and/or interventional procedures.

The ComboWire™/ComboTip™ Pressure/Flow Guide Wire is a steerable guide wire with a pressure transducer mounted less than 3 cm proximal to the tip and a tip mounted ultrasound transducer. The ComboWire/ComboTip measures pressure and flow when used with the ComboMap™ Pressure/Flow Instrument, a class IIa currently marketed device. The ComboWire/ComboTip is currently available in a diameter of 0.014" with a length of 185cm however, additional sensor configurations and wire length will be produced in the future to accommodate customer needs just as has been done with SmartWire, WaveWire and FloWire where up to 10 models are offered. The proximal end of the ComboWire/ComboTip is compatible with the provided ComboWire/ComboTip Connector Cable Assembly. The ComboWire/ComboTip can be torqued using the included torque device to facilitate navigation through the vasculature.

The Volcano Therapeutics, Inc. Volcano IVUS System is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano IVUS System is intended to semi-automatically visualize boundary features and perform spectral analysis of RF ultrasound signals of vascular features that the user may wish to examine more closely during routine diagnostic ultrasound imaging examinations.

The Volcano Therapeutics. Inc. Volcano IVUS System is a combination of proprietary hardware and software and a phantom normalization device. The hardware portion consists of a high-speed computer, with monitor, specifically built for use in medical institutions; high-speed analog-to-digital conversion circuitry and proprietary gating circuitry. The system is connected to the output connectors of conventional IVUS systems and the ECG system using typical cabling. The IVUS radiofrequency output is used directly by the Volcano IVUS System and the ECG output is used to gate or time the collection / recording of the IVUS signal. The software that provides the user interface is Windows 2000 Professional. The Volcano IVUS System applications presently exist in two pieces. The first is the data acquisition package, IVUSLabRF. This application contains the drivers that control the Gage A/D converter card which digitizes the RF data from the IVUS console. It also manages the joining of the data from individual scans that constitute a "slice". The second software program is called IVUSLabVH. This program analyzes each of the slices. These images are visually reviewed and the control points are manually adjusted until they appear in the proper location on the vessel inner and outer borders. Once all the control points have been properly located the software produces a set of data files called "snaxel" files which define the coordinates of the control points. The black and white IVUS files and the snaxel files are loaded into the IVUSLabVH software which processes the data to produce the five color bit mapped Volcano IVUS image files. The system requires the use of a "phantom" to "normalize" the conventional IVUS output. The phantom is a small piece of acrylic material machined to allow placement over the IVUS catheter distal tip.

ComboMap™ Pressure and Flow System is a multi-mode system intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure and/or blood flow velocities during diagnostic angiography and/or interventional procedures.

The ComboMap™ Pressure and Flow System is a computer-controlled (PCbased) instrument, which processes the information it receives from the transducer mounted in a Volcano Therapeutics SmartWire" Pressure Guide Wire, Volcano Therapeutics FloWire® Doppler Guide Wire, and/or external inputs, to produce real-time blood pressure and/or blood flow velocity. There are 4 modes available to operate from and switch between on the ComboMap™; System. Pressure, Flow, and Combo. Depending on the mode and setup selections made, the computer screen displays a combination of waveforms, measured values, and calculated parameters on the display screen. Additional controls also appear on the display screens. In the Pressure Mode, the ComboMap™ provides digital and graphical readout of mean aortic pressure from a guide catheter, mean SmartWire® pressure, and a calculated parameter, such as gradient or fractional flow reserve (FR), and one of six (6) selected waveforms. The ComboMap™ also supplies an analog output of the SmartWire® pressure for display on a conventional physiologic monitoring svstem. In the Flow Mode, there are two (2) operating modes to measure blood flow velocity in either coronary or peripheral vessels. This is because in coronary arteries, maximum blood flow velocity occurs predominantly during diastole and in peripheral arteries, maximum flow occurs during systole. The ComboMap™ displays the waveforms selected and provides digital readout of calculated parameters such as average peak velocity (APV) and flow reserve. The ComboMap™ System offers the unique ability to simultaneously display pressure and velocity waveforms using the Combo Mode. Layout of the Pressure and Doppler display as well as selected waveforms is customized by the user allowing a combination of any of those described above in Pressure Mode and Flow Mode. Depending on the clinicians' preference, the physician has the option of using a pressure guide wire (SmartWire®), a flow guide wire (FloWire®) or both. By using these guide wires from Volcano Therapeutics, the physician can measure pressure and/or flow velocity.