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ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices. General functionalities are provided such as: - Segmentation of neurovascular structures* - Semi-automatic centerline generation from segmented blood vessels* - Visualization of X-ray based images* - Placing and sizing tools for braided endovascular devices - Save user data - Download** and share simulation*** Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider´s judgment and analysis of the patient´s condition. ANKYRAS is available in different platforms: Standalone, WebGL and Mobile App. *Available for Standalone and WebGL platforms **Available for WebGL platform ***Available for WebGL and Mobile App platforms

ANKYRAS is a medical device software application that allows the simulation of neurointerventional endovascular braided devices, such as flow diverters (FDs), and is intended to be used by physicians trained in medical procedures involving percutaneous and intravascular interventions for preoperational planning and sizing for neurovascular interventions and surgery. The software includes a database with braided endovascular FD devices: P100018/S015 - Pipeline Flex Embolization Device and P100018/S026 - Pipeline Flex Embolization Device with Shield Technology, Medtronic, Inc.; P170024/S003 - Surpass Evolve Flow Diverter System, Stryker Neurovascular; P180027 - Flow Re-Direction Endoluminal Device (FRED®) System and P180027/S002 - Flow Re-Direction Endoluminal Device (FRED®) X System, MicroVention, Inc. This database can be customized (among FDA cleared braided endovascular devices previously mentioned) according to the user's institution or needs. ANKYRAS is intended to be used with 3D Rotational Angiography (3DRA) images or with VTK surface models from the target artery. From the 3DRA images, the user can extract the target artery vessel model using ANKYRAS segmentation functionality for further anatomical analysis and computational modeling (simulation) of the listed above FDs: - First, using the vessel model and proximal and distal points selected by the user, ANKYRAS calculates the vessel centerline and displays cross-sectional dimensional information in an interactive chart. - Second, using the vessel model, centerline, and morphology measurements, ANKYRAS simulates the FD devices selected by the user. The user can compare the results between different simulated FD devices and/or different FD positions including simulated device length, expansion along the centerline, and local porosity. The information provided by the software is not intended in any way to eliminate, replace, or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition. ANKYRAS software is intended to be user with a user license and can be installed on a computer with Windows operating systems or installed on an iOS/Android mobile device.

Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures - Automatic centerline detection - Visualization of X-ray based images for 2D review and 3D reconstruction - Placing and sizing tools - Reporting tools Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

Sim&Size is a Software as a Medical Device (SaMD) for simulating neurovascular implantable medical devices. The product enables visualization of cerebral blood vessels for preoperational planning for neurovascular interventions and surgery. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of simulating neurovascular implantable medical devices in the artery or in the aneurysm to be treated through endovascular surgery and provides support in the treatment for the sizing and positioning of implantable medical devices. Each type of implant device is simulated in a simulation module of Sim&Size: - FDsize, a module that allows pre-operationally planning Flow-Diverter (FD) devices. - IDsize, a module that allows pre-operationally planning Intrasaccular (ID) devices. - STsize, a module that allows pre-operationally planning Stent (ST) devices. - FCsize, a module that allows pre-operationally planning First and filling coils (FC) devices. Associated with these four modules, a common module is intended to import DICOM and to provide a 3D reconstruction of the vascular tree in the surgical area.

ANKYRAS enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. ANKYRAS also allows for the ability to computationally model the placement of neurointerventional braided endovascular devices. General functionalities are provided such as: - Segmentation of neurovascular structures - Semi-automatic centerline generation from segmented blood vessels - Visualization of X-ray based images - Placing and sizing tools for braided endovascular devices - Save user data Information provided by the software is not intended in any way to eliminate, replace or substitute for in part, the healthcare provider's judgment and analysis of the patient's condition.

ANKYRAS is a software as a medical device that allows the simulation of neurointerventional braided endovascular devices, such as flow diverters (FDs), and is intended to be used by physicians trained in medical procedures involving percutaneous and intravascular interventions for preoperational planning and sizing for neurovascular interventions and surgery. The software includes a database with FDA-approved FDs: P100018/S015 - Pipeline Flex Embolization Device, Medtronic, Inc.; P170024/S003 - Surpass Evolve Flow Diverter System, Stryker Neurovascular; P180027 - Flow Re-Direction Endoluminal Device (FRED®) System, MicroVention, Inc. ANKYRAS is intended to be used with 3D Rotational Angiography (3DRA) images. From the 3DRA images the user can extract the target artery vessel model using ANKYRAS segmentation functionality for further analysis and computational modeling (simulation) of the listed above FDs: - . First, using the vessel model and proximal and distal points selected by the user, ANKYRAS calculates the vessel centerline and displays cross-sectional dimensional information in an interactive chart. - . Second, using the vessel model, centerline, and dimensions, ANKYRAS simulates the FD devices selected by the user can compare the results between different simulated FD devices and/or different positions including simulated device length, expansion along the centerline, and local porosity. The information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition. ANKYRAS software is intended to be installed on a computer with Windows operating systems.

Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures - Automatic centerline detection - Visualization of X-Ray based images for 2D review and 3D reconstruction - Placing and sizing tools - Reporting tools Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

Sim&Size is a Software as a Medical Device (SaMD) for the simulation of neurovascular implantable medical devices (IMD). The product enables visualization of cerebral blood vessels for preoperational planning for neurovascular interventions and surgery. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally modeling the placement of neurovascular IMD in the artery or in the aneurysm to be treated through endovascular surgery and allows to preoperationally plan the sizing and the positioning of IMD. Sim&Size includes four modules: - FDsize module allows to pre-operationally plan the choice of size of flow-diverter devices; - IDsize module allows to pre-operationally plan the choice of size of intrasaccular devices; - STsize module allows to pre-operationally plan the choice of stents; - FCsize module allows to pre-operationally plan the choice of first and filling embolization coils. Associated to these four modules, a common module is intended to import DICOM images and to provide a 3D reconstruction of the vascular tree in the surgical area.

AneuGuide enables visualization of intracranial vessels for preoperational planning and sizing for neurovascular interventions. AneuGuide also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures . - Automatic centerline detection - . Visualization of X-ray based images for 2D review and 3D reconstruction - . Placing and sizing tools - Reporting tools Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

The AneuGuide software is a medical device intended to provide a 3D view of the final placement of implants. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally modeling the flow diverters (FD) in the artery to be treated through endovascular surgery. AneuGuide is intended to import DICOM images and to provide a 3D reconstruction of the vascular tree in the surgical area. Also, it allows to pre-operationally estimate the size of flow diverter devices. AneuGuide is composed of the following analysis workflows: image loading, selection of the volume of interest (VOI), segmentation threshold adjustment, reconstruction, selection of the region of interest (ROI), selection of the vessel inlet, generation of centerline, initializing the flow diverter, and sizing the flow diverter. The flow diverter supported by the software is the Pipeline Flex Embolization Device (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, PMA: P100018/S015), which is an FDA-approved neurointerventional device. AneuGuide software has a "moderate" level of concern. It is intended only for preoperational planning. It is not intended for diagnosis.

Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures - Automatic centerline detection - Visualization of X-Ray based images for 2D review and 3D reconstruction - Placing and sizing tools - Reporting tools Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

The Sim&Size software is a medical device intended to provide a 3D view of the final placement of implants. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally model neurovascular implantable medical devices (IMD) in the artery or in the aneurysm to be treated through endovascular surgery. IMD such as the flow-diverters (FD) and the intrasaccular devices (ISD). Sim&Size is a software designed with three modules. FDsize is the module that allows to pre-operationally plan the choice of size of flow-diverter devices. IDsize is the module that allows to pre-operationally plan the choice of size of intrasaccular devices. STsize is the module that allows to pre-operationally plan the choice of stent devices. Associated to these three module is intended to import DICOM and to provide a 3D reconstruction of the vascular tree in the surgical area.

Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures - Automatic centerline detection - Visualization of X-Ray based images for 2D review and 3D reconstruction - Placing and sizing tools - Reporting tools Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

The Sim&Size software is a medical device intended to provide a 3D view of the final placement of implants. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally model neurovascular implantable medical devices (IMD) in the artery or in the aneurysm to be treated through endovascular surgery, IMD such as the flow-diverters (FD) and the intrasaccular devices (ISD). Sim&Size is a software designed with two modules. FDsize is the module that allows to preoperationally plan the choice of size of flow-diverter devices. IDsize is the module that allows to preoperationally plan the choice of size of intrasaccular devices. Associated to these two modules, a common module is intended to import DICOM and to provide a 3D reconstruction of the vascular tree in the surgical area. Sim&Size has been simplified as much as possible to guide the user in an intuitive way in order to reduce the total number of actions required and thus to optimize the time taken to obtain the desired results. There are currently seven steps required to choose the optimal size of an IMD to be placed: - 1- Importing the images: the 3D rotational angiography DICOM files are imported. - 2- Selecting of the region of interest (ROI): the user positions and focuses a sphere in the placement zone. - 3- Threshold validation: the user checks the accuracy of the automatically extracted arterial wall. The threshold can be adjusted if needed. - 4- Choosing the entry point: the user clicks on the entry point to the arterial network in order to retrieve the vessel centerlines. - 5- Correct automatically or manually the centerline if needed: the user corrects the centerline going through a vessel fusion with the automatic tool or manually. - 6- Initializing the implant: the user selects an IMD reference and the ideal placement zone. - 7- Sizing the implant: IMD apposition is shown by a color chart in the 3D view. The user can change the IMD reference and placement zone to complete the planning for the intervention. Patient images can be imported into Sim&Size in two ways: the user has the ability to transfer images using an external storage device (e.g. USB stick) or to retrieve images directly from Scanners Workstation if the option is enabled (only the retrieve function is possible). The Sim&Size software is compatible with the operating systems MS Windows and Mac OS, when it is first installed a check is done to verify if the user's computer meets the minimum requirements for the use of the software. When a new version of the software is available, the update can be done by the user through a link send by Sim&Cure, the user then follow the instructions indicated in the user manual or by the use of the updater tool SacUpdates that notifies the user, then assists the download and the installation of the last version. The computational modeling of three devices are supported by the software: Medtronic Pipeline Flex Embolization Device (PED - P100018/S015) flow diverter: Stryker Surpass Evolve Flow Diverter System (Evolve - P170024 S003); and Microvention Woven EndoBridge Aneurysm Embolism System (WEB - P170032) intrasaccular devices. The Medtronic Pipeline Flex Embolization Device, Stryker Surpass Evolve Flow Diverter and Microvention Woven EndoBridge Aneurysm Embolism System devices referenced here are FDA-approved neurointerventional devices.

Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement and deployment of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures - Automatic centerline detection - Visualization of X-ray based images for 2D review and 3D reconstruction - Placing and sizing tools - Reporting tools Information provided by the software is not intended in any way to eliminate, replace or in part, the healthcare provider's judgment and analysis of the patient's condition.

Sim&Size is software that allows for the preoperational planning of medical device sizes for the treatment of intracranial aneurysms. The computational modeling of neurointerventional devices, such as flow diverters and intrasaccular devices, are supported by the software to provide a patient-specific visualization of the deployment of the device from angiographic DICOM data, Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition. The Sim&Size software is intended to be loaded on any Windows- or Mac-OS personal computer. A user license(s) must be purchased from the company in order to use the software after installation. The software also has a training module that offers learning assessments that are relevant to the software. The software interacts with a patient's DICOM images, the user, and the device. To do so, the graphical interface is organized into three graphical pages (or screens): - a. Patient selection page - b. Module selection page - Simulation page C. Sim&Size was designed to enable the visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement, deployment and apposition of neurointerventional devices.

SurgicalPreview enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. SurgicalPreview also allows for the ability to computationally model the placement and deployment of neurointerventional devices. General functionalities are provided such as: - Segmentation of neurovascular structures - Automatic centerline detection - Visualization of CT scan images for 2D review and 3D reconstruction - Measurement and annotation tools - Reporting tools Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

SurgicalPreview" is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview™ provides a clinical decision support system during the preoperative planning of endovascular surgery. SurgicalPreview™ enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview™ also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview™ can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files. The device does not contact the patient, nor does it control any life sustaining devices. Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgement and analysis of the patient's condition.