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The Novasight Hybrid System is intended for intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The Novasight™ Hybrid System is intended for real-time, minimally-invasive guidance of transluminal interventional procedures. The system provides image information of coronary vessel anatomic features, spatial relationships of other devices within the coronary arteries, and intra-procedural complications such as perforation. The system is comprised of a catheter and a cart based console. The console includes the Acquisition and Display Module (ADM) for image acquisition, display and manipulation as well as the Patient Interface Module (PIM) which the catheter connects to. The ADM has two monitors to allow for ease of image view and review for both the technologist and the physician users. The technologist user is able to control the system software via an easy to use interface using multiple methods of input including a trackpad, keyboard and/or a touch screen. Casters on the ADM allow easy movement of the system throughout a cath lab which can have a small footprint as well as small obstacles to cross. The PIM has a user interface for the physician to have control over the acquisition. It is also compact such that it can be moved and handled by an able-bodied user. The system includes software build version 2.0 (2.0.6607.31062). The catheter is a 3Fr single use, sterile device, which is able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. The imaging system is able to resolve features within coronary arteries such as healthy tissue and stent struts. The physician user has the ability to manually position the imaging sensor as well as perform pullback (automatically or manually trigger) for defined regions of interest.

The Foresight Intracardiac Echocardiography (ICE) System is indicated for intraluminal ultrasound visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart and great vessels of patients.

The Foresight ICE System is intended to be used for real-time, minimally-invasive guidance of several different intracardiac procedures including, but not limited to, atrial ablation procedures and transseptal punctures. The system will provide image information of cardiovascular anatomic features, spatial relationships of other devices within the heart and great vessels, physiological information of cardiovascular structures and features, and intra-procedure complications including pericardial effusions. The system will be comprised of catheter and a cart based console. The console includes the Acquisition and Display Module (ADM) for image display and manipulation as well as the Patient Interface Module (PIM) which the catheter connects to. The ADM will have two monitors to allow for ease of image view and review for both the technician and physician user. The technician user will be able to control the system software via an easy to use interface using multiple methods of input including a mouse, keyboard and/or a touch screen. Casters on the ADM will allow easy movement of the system throughout an EP Lab which can have a small footprint as well as small obstacles to cross. The catheter will be a 10.3F single use, sterile device, which will be able to perform intracardiac and intraluminal ultrasound imaging of adults. The catheter will be capable of real-time 2D side and forward viewing imaging with the ability to produce rapidly post processed 3D rendered images as well as ECG gated 3D images to reduce motion artifacts. The imaging system will be able to resolve and measure features such as the inferior and superior vena cava, ascending and descending aorta, left and right atria, left and right ventricle, fossa ovalis, aortic valve, mitral valve and tricuspid valves. It will display / measure flow velocities using Color and PW Doppler. The physician user will have easy steering maneuverability of the catheter via deflection and rotation, as well as having control over the position of the transducer to allow for multiple angles of images.