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The NEUWAVE™ Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors. The NEUWAVE™ Microwave Ablation System is not indicated for use in cardiac procedures

The NEUWAVE™ Microwave Ablation System is a self-contained stand-alone system of hardware and software designed for the ablation of soft tissue which applies microwave energy to produce tissue heating effects generating tissue necrosis. The system consists of three major components (1) a cart which contains the components necessary to deliver microwave power to the microwave ablation probes, monitor and control system functions, a graphical user interface for the user to interact with the system and a CO2 based cooling system, (2) a Power Distribution Module (PDM), and (3) a range of microwave ablation probe accessories for energy delivery. The system has a single 2.45 GHz signal microwave source with three 140W microwave power amplifiers, a touch-screen graphical user interface, and a CO2 based cooling system for limiting the temperature of the ablation probe, handle, and cable. The CO2 cooling system enables the Tissu-Loc function, which involves formation of an ice ball to adhere the probe in place prior to starting ablation therapy. This helps eliminate probe migration during imaging (CT scans, ultrasounds, etc.) and additional probe placement. The cooling system is responsible for controlling the pressure of the incoming CO2 gas from two E-sized CO2 cylinders located on the back of the system. The graphical user interface allows the user to set, adjust and activate the power setting per probe, time setting for each probe, ability to synchronize ablation initiation on probes, ablation activation, cauterization activation, audible volume, probe temperature, and Tissu-Loc function. Up to three (3) NEUWAVE Ablation Probes can connect to the PDM at once and the PDM allows power to be transferred from the system generator to the ablation probes. The microwave ablation probes are accessories which transfer microwave energy from the system cart to the target tissue to create regions of thermal necrosis. Each probe contains thermocouples that monitor the temperature of the probes can be used for surgical mode or ablation mode with various limits of maximum selectable power and time based on the probe type.

Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the Certus® 140 2.45 GHz Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the Certus 140 user interface. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures. AC assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones. The software is not intended for diagnosis.

AC is resident on the Certus® 140 system and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. AC functions are controlled via a USB connected mouse. AC connects to a facility PACS system and CT scanner and receives and sends CT and MR images via the DICOM protocol. AC contains a wide range of image processing tools, including: - 2D image manipulation - 3D image generation (from 2D images) - 3D image manipulation - Region of interest (ROI) identification, segmentation and measurement - Automatic identification of ablation probes - . Registration of multiple images into a single view Prior to an ablation procedure, physicians can use AC to semi-automatically segment and visualize ablation target lesions in soft tissue including liver, lung and kidney. The physician initiates the segmentation with tools provided on the screen. AC then uses segmentation algorithms to construct a 2-D visualization of the target lesion selected. The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion. Once accepted, the identified target is rendered into a 3D image. Upon the placement of ablation probes, taking and importing the CT scan, AC can process the image and identify up to three ablation probes. AC can then perform a registration of the initial CT scan, containing the identified target with the second scan containing the ablation probe(s) in place. The resulting image allows the physician to visualize the ablation probe(s) in relation to the identified target. This enables physicians to ensure proper probe(s) placement prior to starting the ablation. Following the ablation procedure and a post-procedure CT scan, AC allows the physician to semi-automatically segment and visualize the ablation zone using the same process as in the initial target segmentation. AC can then performs a registration of the initial CT scan, containing the identified target, with the final CECT scan containing the segmented ablation zone. The resulting image set includes the ablation zone overlaid onto the initial target lesion segmentation to help physicians determine the technical success (ablation zone covers target lesion with desired amount of margin) of the ablation procedure. All AC processing and viewing is accomplished at the Certus® 140 Ablation System without the physician having to leave the procedure area to utilize separate image processing tools. Additionally, AC allows for the images to be viewed by a remote physician for time-saving clinical consultation on the current procedure.