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The ILUMIEN OPTIS 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 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 with the cable underground. 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 C7 XR™ Imaging System with C7 Dragonfly™ 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™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 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 C7 XR™ Imaging 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 C7 XR™ Imaging System K093857 (C7 XR) and Dragonfly™ Imaging Catheter (Dragonfly Catheter or DF) provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system 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 C7 XR will include two USB receivers to accept radiofrequency signals from a distal intracoronary pressure transducer and a proximal aortic pressure transducer and display the acquired pressure waveforms and calculated Fractional Flow Reserve on the C7 XR system monitor. The C7 with FFR system consists of the following components: C7 XR Imaging System (K093857): A cart-mounted computer and optical engine control the device and function as user interface, display and data storage. It includes the Drive-motor and Optical Coupler (DOC). The DOC is an optical-electro-mechanical device that provides the optical interconnection between the C7 XR and Dragonfly Catheter, and controls the rotational and axial motion of the fiber-optic core within the catheter and will include two USB receivers to accept radiofrequency signals from the distal intracoronary pressure transducer and a proximal aortic pressure transducer.

The C7 XR™ Imaging System with C7 Dragonfly™ 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™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 DragonflyTM 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 C7 XR™ Imaging System (C7 System) and C7 Dragonfly™ Imaging Catheter (Dragonfly Catheter) provide images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The system utilizes fiber-optic technology to transmit and receive light reflected from coronary tissue in order to produce high resolution, real-time images. The system consists of the C7 XR™ Imaging System (cart-mounted computer and optical engine), the C7 Dragonfly™ Imaging Catheter and Disposable Accessories (sterile, single-use catheter with fiber optic imaging core and external sheath), and the Off-line Review Workstation (personal computer with software to import, maintain and review images).