Search Results

The OPTIS™ Software with Dragonfly™ DUO or Dragonfly™ OPTIS™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ DUO or Dragonfly ™ OPTIS™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ DUO or Dragonfly™ OPTIS™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS™ Software will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The Metallic Stent Optimization SW E.4 is an OCT system software that allows update of the current software version of ILUMIEN OPTIS (K150878), OPTIS Mobile System (K152120) and OPTIS Integrated OCT Systems (K151286) on the field for the Stent Optimization Tool features. The Metallic Stent Optimization SW E.4 is also compatible with flush catheters compatible with the above mentioned OCT systems (Dragonfly OPTIS and Dragonfly DUO catheters). The OCT system software is used to control the OCT imaging engine in order to acquire OCT images, it is used to make measurements based on acquired OCT images, it is used to maintain a database of OCT images and data, and it is used to review previously acquired OCT images and data. The OCT System software is also used to control the Aortic (AO) and PressureWire (PW) USB receivers to collect and store pressure waveform data for computing Fractional Flow Reserve (FFR). Similar to the OCT images, the FFR waveforms are stored in the database and are available for later review. The OPTIS™ Metallic Stent Optimization E.4 SW software runs on 64-bit Microsoft Windows 7 Embedded Operating System only. The software also contains Intel JPEG Library, Microsoft MPEG-4 Video Codec, Microsoft Video 1 codec, AMD FirePro V4900 Display Adapter Driver, Intel 82579LM/82583V Gigabit Ethernet Controller Driver, Microsoft Foundation Class Library, Active Template Library, Microsoft Standard C++ Library, LEADTOOLS Medical Imaging Suite SDK, Microsoft SQL Server Express 2008 Service Pack 2 (SP2), Open Inventor Library, Haru PDF Library, IDEA Video Driver, iWRAP Bluetooth Stack and Intel Integrated Performance Primitives commercial off the shelf (COTS) software. The E.4 software introduces the following new features: - . 3D Flythrough, 3D Bifurcation (Bifurcation Visualization)- Enhance assessment of ostium geometry with optimized 3D views - Cross Frame Angio (Stent Roadmap) Display stent roadmap with . OCT/angiography coregistrations - Stent Display (Quantification of Stent Strut Apposition, Metallic Stent . Visualization) and 3D Display Options (Guide Wire Detection, Side Branch Detection) - Provide intra-procedural guidance by automatic detection and 3D visualization of BMS struts, side branches, and guidewires

The OPTISTM Mobile System with DragonflyTM DUO or DragonflyTM OPTISTM Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The DragonflyTM DUO or Dragonfly™ OPTISTM Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ DUO or DragonflyTM OPTISTM Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTISTM Mobile System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The OPTIS Mobile System is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with the cable underground. It includes the Drive-motor and Optical Coupler (DOC), which provides the interconnection between the OPTIS Mobile System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety. The cart includes two USB mounted FFR receivers which provide wireless reception of distal intracoronary and aortic pressure signals originating at the PressureWire® Aeris and the aortic pressure transducer (AIU). These signals are used to calculate and display the patient's Fractional Flow Reserve (FFR) on the system monitor. The OPTIS Mobile System is comprised of the following main components: - . A rapidly scanning laser engine - A host computer with embedded application software ● - A drive-motor and optical coupler (DOC) which connects to the imaging catheter ● - A mobile console with monitors, keyboard and mouse housing laser engine and host computer, and connected to the DOC. - An imaging catheter - An optional Tableside Controller (TSC) ● - o Video interfaces for interaction with the boom monitor and angiography system The function of the Tableside Controller (TSC) is to provide tableside system control to the Physician. The TSC communicates with the console via wireless configuration or an optional wired configuration. The OPTIS Mobile System can perform both OCT and FFR procedures, and is compatible with Dragonfly OPTIS, DUO and JP catheters and the PressureWire Aeris. The OPTIS Mobile system provides the ability to incorporate the angiography images into the GUI, which allows users to visualize the position of OCT image data on angiography images, tightening the linkage between anatomical assessment with OCT and subsequent therapeutic actions.

The OPTIS Integrated System with Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly DUO or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS Integrated System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The OPTIS Integrated System performs optical coherence topography (OCT) and fractional flow reserve (FFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The device utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real time images. The imaging engine generates wavelength scanning light, which is guided to the DOC and the catheter. The reflection is collected and sent back to the engine. The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images. The device is compatible with Dragonfly OPTIS, Dragonfly Duo and PressureWire Aeris. The OPTIS Integrated System configuration has the following components integrated into a single catheterization lab. | Component | Location | |------------------------------------|---------------------------------------------------------------------| | Laser and<br>Engine | Contained within the system cabinet (M5a) | | PC Embedded<br>Software | Contained within the system cabinet | | DOC | Located on the table side,<br>connected directly to the DOC Holster | | Monitor<br>Keyboard<br>Video Mouse | Located in the control room | | System<br>Cabinet | Located within the control room or technical closet | | Remoting<br>Cable | The cable connects the DOC Holster to the system cabinet | | DOC Holster | Located table side | | Tableside<br>Controller | Located table side | The OPTIS Integrated System Mobile Workstation (MWS) is an accessory for the OPTIS Integrated System. The MWS is a mobile terminal that mirrors the functionality of the control room monitor, keyboard and mouse that is part of the OPTIS Integrated System. The Control room monitor, keyboard and mouse of OPTIS Integrated System is a desktop setup located in the control room for operating system controls. The MWS consists of two major subassemblies: - MWS console is comprised of a cart, keyboard, mouse, monitor, wireless . Keyboard/Video/Mouse (KVM) receiver, cabling, branding labels and compliance label. - MWS transmitter is comprised of a wireless KVM transmitter, video splitter, power supplies and cabling. All items are shipped together in a single carton.

The ILUMIEN with C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The ILUMIEN will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated. The Dragonfly OPTIS Imaging Catheter with the OCT Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary.

The ILUMIEN is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart with a mains power cable. It also includes the Drive-motor and Optical Controller (DOC), which provides the interconnection between the ILUMIEN System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety and includes two AO and PW USB Receivers which accept the distal intracoronary and proximal aortic pressure signals and status information from the AO Interface Unit and PressureWire® Aeris (K080813) respectively, and communicate the FFR data for display on the ILUMIEN system. The Dragonfly OPTIS Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the inner rotating fiber optic imaging core. The inner rotating fiber optic imaging core emits near infrared light to the tissue and receives reflected light. It is driven by a stainless steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the DOC. The emitted and returned reflected light are combined and processed by the ILUMIEN Optis System software to construct an OCT image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.

The ILUMIEN OPTIS with C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The ILUMIEN OPTIS will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart. It also includes the Drive-motor and Optical Coupler (DOC), which provides the interconnection between the ILUMIEN OPTIS System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety. The cart includes two USB mounted FFR receivers which provide wireless reception of distal intracoronary and aortic pressure signals originating at the PressureWire® Aeris and the aortic pressure transducer (AIU). These signals are used to calculate and display the patient's Fractional Flow Reserve (FFR) on the system monitor. The Dragonfly OPTIS Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the inner rotating fiber optic imaging core. The inner rotating fiber optic imaging core emits near infrared light to the tissue and receives reflected light. It is driven by a stainless steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the DOC. The emitted and returned reflected light are combined and processed by the Ilumien Optis System software to construct an OCT image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.

The OPTIS Integrated System with C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The OPTIS Integrated System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter. Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The OPTIS Integrated System performs optical coherence topography (OCT) and fractional flow reserve (FFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The device utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real time images. The imaging engine generates wavelength scanning light, which is guided to the DOC and the catheter. The reflection is collected and sent back to the engine. The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images. The devices is compatible with Dragonfly OPTIS, Duo, and I imaging catheters, in addition to the PressureWire Aeris. The Dragonfly OPTIS Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the inner rotating fiber optic imaging core. The inner rotating fiber optic imaging core emits near infrared light to the tissue and receives reflected light. It is driven by a stainless steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the DOC. The emitted and returned reflected light are combined and processed by the OPTIS Integrated System software to construct an OCT image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.

The ILUMIEN OPTIS with Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The ILUMIEN OPTIS will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

The ILUMIEN OPTIS is a cart-mounted computer and Imaging Engine (or optical engine) placed inside an ergonomically designed mobile cart. It also includes the Drivemotor and Optical Controller (DOC), which provides the interconnection between the ILUMIEN OPTIS System and the Dragonfly Catheter. The cart is equipped with two display monitors (one for the console operator, and the other for the physician), as well as a keyboard and mouse. The cart also contains an isolation transformer for electrical safety. The cart includes two USB mounted FFR receivers which provide wireless reception of distal intracoronary and aortic pressure signals originating at the PressureWire® Aeris and the aortic pressure transducer (AIU). These signals are used to calculate and display the patient's Fractional Flow Reserve (FFR) on the system monitor.