Search Results

EndoNaut is an image fusion software solution and computerized navigational system intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices. EndoNaut is indicated for use by Physicians for patients undergoing a fluoroscopy X-ray guided procedure in the chest, abdomen, pelvis, neck and lower limbs, such as aneurysm repair, artery/vein embolization, or peripheral artery disease treatment. The information provided by the software or system is in no way intended to substitute for, in whole or in part, the surgeon's judgment and analysis of the patient's condition. It is mandatory to check the real-time anatomy with a suitable imaging technique, such as a contrast-enhanced angiography, before deploying any invasive medical device.

EndoNaut is a computerized navigation system consisting of a software part that carries the medical features and technologies that are controlled and can be installed on a hardware part that enables the medical device to be used in accordance with its intended purpose. EndoNaut is intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices. EndoNaut Software parts are supported by hardware and software accessories which enable image display and an interaction with the user. The Software part is interoperable with EndoSize which is a standalone Software designed and developed by Therenva to enable case planning strategy and device (endoprosthesis) selection be-fore endovascular procedure. EndoSize is used by practitioners (in the preparation phase of the operating procedure) or by endoprosthesis manufacturers to visualize vascular structures and/or carry out an extract of the vascular structure from the preoperative CT scan. EndoSize is medical device software which obtained a substantial equivalence determination and FDA clearance through the CDRH premarket notification process (510(K)) (NºK160376).

EndoNaut is indicated for the treatment of patients with endovascular diseases and who needs, such as but not limited to the following examples: - · endovascular aortic aneurysm repair (AAA and TAA), - · angioplasty, - · stenting. - · embolization in iliac arteries and corresponding veins. EndoNaut is indicated for endovascular procedures in the thorax, abdomen, pelvis and lower limbs.

EndoNaut system is an imaging solution for intraoperative navigation and guidance tool for endovascular procedures (aorto-iliac and peripheral). EndoNaut provides localization assistance by combining 3D preoperative scans and 2D intra-operative fluoroscopy imagery to help position guides, catheters and other vascular devices. EndoNaut Software is interoperable with EndoSize which is a standalone Software designed and developed by Therenva to enable case planning strategy and device (endoprosthesis) selection before endovascular procedure.

EndoNaut provides image guidance by overlaying preoperative 3D vessel anatomy onto live fluoroscopic images in order to assist in the positioning of the guidewires, catheters and other endovascular devices. EndoNaut is intended to assist endovascular procedures in the thorax, abdomen, neck, pelvis and lower limbs. Suitable procedures include (but not limited to) endovascular aortic aneurysm repair (AAA and TAA), angioplasty, stenting and embolization in iliac arteries and corresponding veins. EndoNaut is not intended for use in the X-ray guided procedures in the liver, kidneys or pelvic organs.

EndoNaut is a stand-alone software medical device that runs on a Windows based computer that meets the minimum requirements. EndoNaut software provides navigation tools for image-guided endovascular surgery. The device enables to register the X-ray intra-operative images and the pre-operative data. The device is operated by the physician or a trained operator. The client machine captures a live fluoroscopy video feed from the X-ray's machine external video port, either in digital or in analog format. Any machine that meets the hardware and software requirements can be supported. The EndoNaut will be marketed as a software only solution.

EndoSize is a software solution that is intended to provide Physicians and Clinical Specialists with additional information to assist them in reading and interpreting DICOM CT scan images of structures of the heart and vessels. EndoSize enables the user to visualize and measure (diameters, lengths, volumes, angles) structures of the heart and vessels. Indications for Use: EndoSize enables visualization and measurement of the heart and vessels for preoperational planning and sizing for cardiovascular interventions and surgery, and for postoperative evaluation. General functionalities are provided such as: - Segmentation of cardiovascular structures - Automatic and manual centerline detection - Visualization of CT scan images in every planes, 2D review, 3D reconstruction, Volume Rendering, MPR, Stretched CMPR - Measurement and annotation tools - Reporting tools

EndoSize is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables Physicians and Clinical Specialists to select patient CT scan studies from various data sources, view them, and process the images thanks to a comprehensive set of tools. EndoSize is intended to provide a clinical decision support system during the preoperative planning of endovascular surgery. EndoSize contains five modules dedicated to different types of endovascular interventions, EndoSize EVAR, EndoSize FEVAR, EndoSize TEVAR, EndoSize TAVI and EndoSize Peripheral. These modules can be marketed in combination or as separate solutions. It is also possible to market custom versions of EndoSize to Stent manufacturers, based on the modules listed above. The differences between EndoSize and a custom version of EndoSize (user interface, manufacturer logo, manufacturer stent catalogue in the software, optional features of a generic module), do not modify neither the functioning nor the safety of the software. One custom version of EndoSize is marketed under the trademark "Intelix". This version includes the modules Intelix AFX and/or Intelix AFX2 and/or Intelix NELLIX which are customized versions of EndoSize EVAR module for specific endografts. EndoSize enables assessment and measurement of different vascular structures such as vessels, valves, aneurysms, and other anomalies. It provides simple to assess the feasibility of endovascular procedures. EndoSize can combine 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. The software accurately represents different types of tissue, making it easier to diagnose anomalies in scans. It works with DICOM CT scan images and can access multiple DICOM data files and PACS server.

EndoSize is a software solution that is intended to provide Physicians and Clinical Specialists with additional information to assist them in reading and interpreting DICOM CT scan images of structures of the heart and vessels. EndoSize enables the user to visualize and measure (diameters, lengths, volumes, angles) structures of the heart and vessels. EndoSize enables visualization and measurement of the heart and vessels for pre-operational planning and sizing for cardiovascular interventions and surgery, and for postoperative evaluation. General functionalities are provided such as: - Segmentation of cardiovascular structures - Automatic and manual centerline detection - Visualization of CT scan images in every planes, 2D review, 3D reconstruction, Volume Rendering, MPR, Streiched CMPR - Measurement and annotation tools - Reporting tools

EndoSize is a stand-alone software application that runs on any standard Windows or Mac OSX based computer which meets the minimal requirements. It enables Physicians and Clinical Specialists to select patient CT scan studies from various data sources, view them, and process the images thanks to a comprehensive set of tools. EndoSize is intended to provide a clinical decision support system during the preoperative planning of endovascular surgery. EndoSize contains five modules dedicated to different types of endovascular interventions, EVAR, FEVAR, TEVAR, TAVI and Peripheral. These modules can be marketed in combination or as separate solutions. It is also possible to market custom versions of EndoSize to Stent manufacturers, based on the modules listed above. The differences between EndoSize and a custom version of EndoSize (user interface, manufacturer logo, manufacturer catalogue included in the software, of a generic module) do not modify neither the functioning nor the safety of the software. EndoSize enables assessment and measurement of different vascular structures such as vessels, valves, aneurysms, and other anomalies. It provides simple techniques to assess the feasibility of endovascular procedures. EndoSize can combine 2D scan slices into comprehensive 3D models of the patient, and can display supporting DICOM CT scan data. The software accurately represents different types of tissue, making it easier to diagnose anomalies and plan interventional procedures. It works with DICOM CT scan images and can access multiple DICOM data files and PACS server.