Intrasaccular Devices
Sim&Size
Indications for Use
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.
Key Specifications
- Software as a Medical Device (SaMD) for simulating neurovascular implantable medical devices
- Uses patient images from 3D rotational angiography
- Modules: FDsize for Flow-Diverter devices, IDsize for Intrasaccular devices, STsize for Stent devices, FCsize for First and filling coils devices
- Common module for DICOM import and 3D vascular tree reconstruction
- 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
- Runs on MS Windows and Mac OS
- Compatible with local DICOM files or PACS servers
- No patient contact
- Image processing: Orthogonal views, color volume rendering, active presets, 3D view of device assemblies
- Assessments: Apposition indication along arterial/aneurysm wall, Volume embolization ratio for coils, Metal surface coverage for flow diverters, Reconstructed structure measurements, Simulated implant dimensions measurements
- FDsize module supports: Medtronic Pipeline Flex (P100018/S15), Pipeline Flex with Shield Technology (P100018/S026), Pipeline Vantage with Shield Technology (P100018/S034), Stryker Surpass Evolve (P170024/S003), Stryker Surpass Elite (P170024/S012), MicroVention FRED (P180027), FRED X (P180027/S002)
- IDsize module supports: MicroVention Woven EndoBridge (WEB – P170032)
- STsize module supports: Stryker Neuroform Atlas (P180031/S001), MicroVention LVIS and LVIS Jr (P170013), MicroVention LVIS EVO (P170013/S004)
- FCsize module supports: Medtronic Axium Detachable Coil and Axium Prime (K233420), MicroVention HydroCoil Embolic System (K161367), Stryker Target and Target XXL (K161429), Stryker Target Tetra (K222533), Balt Optima Coil System (K223386)
- Pull-down maneuver simulation for flow diverter deployment in fusiform aneurysms (FDsize module)
- Compression indication of implant along aneurysm wall (IDsize module)
- Outputs: Simulation report in PDF and DCM format, Arterial reconstruction in DCM and VTP format
- Data interchange: Import (manual/automatic), Export, Deletion, Anonymization, Search
- Compatible with DICOM image data from 3D rotational angiography stations
Description
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.