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 simulation of neurovascular implantable medical devices
- Uses patient images from 3D rotational angiography
- Includes four modules: FDsize for flow-diverter devices, IDsize for intrasaccular devices, STsize for stents, FCsize for first and filling embolization coils
- Common module for importing DICOM images and 3D reconstruction of vascular tree
- Supports computational modeling of specific devices: Medtronic Pipeline Flex (PED – P100018/S015), Pipeline Flex with Shield (PED2 – P100018/S026), Stryker Surpass Evolve (P170024/S003), MicroVention FRED (P180027), FRED X (P180027/S002)
- IDsize supports MicroVention WEB (P170032)
- STsize supports Stryker Neuroform Atlas (P180031), MicroVention LVIS and LVIS Jr (P170013)
- FCsize supports Medtronic Axium and Axium Prime (K203432), MicroVention HydroCoil (K161367)
- General functionalities: 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
- New features: Automated region of interest initialization, Vessel wall threshold, Vessel entry point features, Ability to computationally model overlapped flow-diverters
- Regulation Number: 21 CFR 892.2050
- Product Code: PZO
- Class II device
Description
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.