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The Verrata PLUS pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to guide the positioning of a balloon dilatation cather interventional devices. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

The Verrata PLUS pressure guide wire (hereafter referred to as the "pressure guide wire") is a steerable guide wire with a pressure transducer mounted 3 cm proximal to the tip. The Verrata PLUS guide wire measures pressure when used with the SmartMap, ComboMap, s5 Series, CORE , and IntraSight series of systems. This pressure guide wire will not operate if connected to any other imaging system. The pressure guide wire has a diameter of 0.014" (0.36 mm) and is available in lengths of 185 cm or 300 cm and in straight or pre-shaped tips. The pressure guide wire is packaged attached to the connector with a torque device to facilitate navigation through the vasculature.

The IntraSight System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated 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 vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. Rotational 45MHz feature is intended for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vasculature as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and the wall structures. The Pullback feature of the imaging core within the protective sheath for a maximum of 15 cm. The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

The IntraSight Mobile System provides qualitative and quantitative evaluation of vascular morphology in the coronary arteries and peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The IntraSight Mobile System interfaces with Volcano Intravascular Ultrasound (IVUS) Imaging Catheters and pressure wires. When operating in the IVUS mode, the IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures and produce a 360° cross-sectional, tomographic image. When operating in the pressure mode, the system acquires intraluminal data from pressure guide wire while simultaneously taking aortic pressure data from the established catheterization lab equipment. Catheters and guide wires are connected to the system via the Patient Interface Module (PIM).

The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

The OmniWire pressure guide wire is a steerable guide wire with a pressure sensor mounted 3 cm proximal to the tip. The pressure guide wire measures pressure when used with the IntraSight and CORE Series of systems and is intended to be used in adult patients eligible for endovascular procedures. The pressure guide wire has a diameter of 0.014" (0.36 mm), a length of 185 cm and is available in straight or pre-shaped tips. It is coated with hydrophilic coating (39 cm length) on the distal portion to reduce surface friction and enhance lubricity. It is also coated with a hydrophobic coating (146 cm length) on the proximal portion to reduce surface friction. The pressure guide wire is packaged attached to the connector with an OmniWire-specific torque device to facilitate navigation through the vasculature.

The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

The OmniWire pressure guide wire is a steerable guide wire with a pressure sensor mounted 3 cm proximal to the tip. The pressure guide wire measures pressure when used with the IntraSight and SmartMap systems and is intended to be used in adult patients eligible for endovascular procedures. The pressure guide wire has a diameter of 0.014" (0.36 mm), a length of 185 cm and is available in straight or preshaped tips. It is coated with hydrophilic coating (39 cm length) on the distal portion to reduce surface friction and enhance lubricity. It is also coated with a hydrophobic coating (146 cm length) on the proximal portion to reduce surface friction. The pressure guide wire is packaged attached to the connector with an OmniWire-specific torque device to facilitate navigation through the vasculature.

The SyncVision System is an image acquisition and processing system. It is indicated for use as follows: - To provide quantitative information regarding the calculated dimensions of arterial segments. - To enhance visualization of the stent deployment region. - To be used in-procedure in the catheterization lab and off-line for post-procedural analysis. - To obtain a co-registration of an angiographic x-ray image and IVUSimages. - To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values.

The SyncVision System (the System) is an image acquisition and processing workstation situated in the coronary catheterization laboratory and is intended to be used during coronary catheterization procedures. The SyncVision System captures angiographic and intravascular ultrasound (IVUS) image streams, as well as physiological (FFR/iFR) displayed value streams, and works in conjunction with currently marketed Volcano IVUS Systems. The SyncVision System intends to capture the fluoroscopic image stream on line and perform the following functions in order to assist interventional cardiologist in visualizing and quantifying the information resulting from images produced by the existing imaging modalities: - . During lesion evaluation: Angiogram selection, quantitative coronary measurements (lesion diameters, length, and percent stenosis) and vessel region enhancement are performed instantly and on line. - . During device positioning, deployment and post-deployment, an on-line enhanced image stream is displayed side-by-side to the existing Fluoroscopic image stream. - Import and display of image data from endoluminal modalities, lead to a joint display of images acquired by X-ray and endoluminal imaging, and correspond to the same selected luminal locations or segments (also known as co-registration of such modalities). - Import and display of values derived from intracoronary pressure measurements lead to a joint display of images acquired by X-ray and pressure values, and correspond to the same selected locations or segments (also known as co-registration of such modalities). The objective of the SyncVision System is to optimize and facilitate trans-catheter cardiovascular interventions by means of automated on-line image processing. The current focus of the SyncVision System is on trans-catheter diagnostic and therapeutic interventions performed on the heart and the blood vessels directly connected to it.

The IntraSight System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated 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 vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. The pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. Rotational 45MHz feature is intended for the qualitative evaluation of vascular morphology in the coronary arteries and vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the Spinvision (PIMr) withdraws the imaging core within the protective sheath for a maximum of 15 cm. The FFR Modality is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

The IntraSight System provides qualitative and quantitative evaluation of vascular morphology in the coronary arteries and peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The IntraSight System interfaces with Volcano Intravascular Ultrasound (IVUS) Imaging Catheters and pressure wires. When operating in the IVUS mode, the IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures and produce a 360° cross-sectional, tomographic image. When operating in the pressure mode, the system acquires intraluminal data from a pressure guide wire while simultaneously taking aortic pressure data from the established catheterization lab equipment. Catheters and guide wires are connected to the system via the Patient Interface Module (PIM).

The Volcano 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 indicated 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 vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion. VH IVUS is intended to be used in conjunction with imaging catheters during diagnostic ultrasound imaging of the peripheral and coronary vasculature. The Volcano VH 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 pressure feature is intended for use in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. Rotational 45MHz feature is intended for the qualitative evaluation of vascular morphology in the coronary arteries and vasculature as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and the wall structures. The Pullback feature of the imaging core within the protective sheath for a maximum of 15 cm. The FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure angiography and/or interventional procedures. The iFR Modality is intended to be used in conjunction with currently marketed Volcano pressure wires. In the coronary anatomy, the iFR modality has a diagnostic cut-point of 0.89 which represents an ischemic threshold and can reliably guide revascularization decisions during diagnostic catheterization procedure. When used as for a pullback assessment, the iFR modality is intended as a visual aid in decision making the relative location and severity of the stenoses such as, multiple lesions or diffuse disease.

The Volcano s5 TM/s5i/CORETM Mobile Precision Guided Therapy System is a mobile imaging and pressure management system as previously described in K133323. The subject device incorporates the Volcano iFR® Modality cleared in K133323. Pressure measurement is captured through the use of currently marketed pressure wires compatible with the currently marketed s5/s5i/CORE/CORE Mobile imaging and pressure measurement system.

The CORE M2 Vascular System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated 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 vasculature; flow information can be an adjunct to other methods of estimating blood flow and blood perfusion.

The CORE M2 Vascular 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 indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The system utilizes the acoustic impedance of vascular structures to provide cross sectional images from inside the vessel. The IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures to produce a 360° cross sectional grayscale image. In addition to producing grayscale IVUS images, the CORE M2 System with Software v4.2 provides the ChromaFlo feature which can be used to identify blood flow. The ChromaFlo feature uses patented technology to provide a visual depiction of blood flow through the vessel. This is accomplished by overlaying a two-dimensional color mapping of relative blood flow velocity on to the grayscale ultrasound image. The CORE M2 Vascular System consists of a cart mounted touchscreen PC Console, a patient interface module (PIM) for connecting the IVUS Imaging Catheter to the PC Console, and an optional Control Console as an alternative to the touchscreen for control of the CORE M2 System.

The Sync Vision System is an image acquisition and processing system. It is indicated for use as follows: - To provide quantitative information regarding the calculated dimensions of arterial segments. - To enhance visualization of the stent deployment region. - To be used in-procedure in the catheterization lab and off-line for post-procedural analysis. - To obtain a co-registration of an angiographic x-ray image and IVUS images. - To obtain a co-registration of an angiographic x-ray image and intravascular blood pressure values.

The SyncVision System (System) is displayed on a monitor that is situated next to the native xray, IVUS and FFR/iFR imaging and displayed value streams either in the cath lab or in the control room. The System provides a means to view the angiographic, IVUS, and FFR/IFR values on a single display and automates the manual registration processes performed by the physician. The objective of the SyncVision System is to optimize and facilitate trans-catheter cardiovascular interventions by means of automated on-line image processing. The current focus of the SyncVision System is on trans-catheter diagnostic and therapeutic interventions performed on the heart and the blood vessels directly connected to it. The SyncVision System's core component is an image acquisition and processing workstation situated in the coronary catheterization control room. The System also includes additional components such as a procedure room joystick, control room monitor, keyboard and mouse, medical grade isolation transformer along with site-specific cables and video equipment. Cables also connect the workstation to an existing output monitor (not supplied with the System) situated in the procedure room and provide the user in the procedure room with the visual output of the System side-by-side to the existing displays. The SyncVision System intends to capture the fluoroscopic image stream on line and perform the following functions for the purpose of assisting the interventional cardiologist in visualizing and quantitating the information resulting from images produced by the existing imaging modalities: During lesion evaluation: Angiogram selection, quantitative coronary measurements (lesion diameters, length, and stenosis percentage), vessel region enhancement and vessel region stabilization are performed instantly and on line. During device positioning, deployment and post-deployment: An on-line image stream, that is enhanced and stabilized, is displayed side-by-side with the existing fluoroscopic image stream. Import and display of IVUS images, leading to a joint display of images acquired by X-Ray and IVUS images corresponding to same selected luminal locations or segments (also known as IVUS Co-registration). Import and display of Physiological values, leading to a joint display of images acquired by X-Ray and Physiological values corresponding to same selected luminal locations or segments (also known as Physiological Co-registration).

The CORE M2 Vascular System is used for the qualitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. It is also indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures.

The CORE M2 Vascular 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 indicated as an adjunct to conventional angiographic procedures to provide an image of vessel lumen and wall structures. The system utilizes the acoustic impedance of vascular structures to provide cross sectional images from inside the vessel. The IVUS catheter uses a transducer near the distal tip to emit and receive high frequency sound waves. The system is then able to analyze the signal that is received by the transducer to differentiate between vessel structures to produce a 360° cross sectional image. The CORE M2 Vascular System consists of a cart mounted touchscreen PC Console, a patient interface module (PIM) for connecting the IVUS Imaging Catheter to the PC Console, and an optional Control Console as an alternative to the touchscreen for control of the CORE M2 System.