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 for visualization of vascular anatomy and intravascular devices
- Uses 3D rotational angiography DICOM files
- Two modules: FDsize for pre-operational planning of flow-diverter devices, IDsize for intrasaccular devices
- Common module for DICOM import and 3D reconstruction of vascular tree
- Seven-step process: importing images, selecting region of interest (ROI), threshold validation, choosing entry point, correcting centerline (automatic/manual), initializing implant, sizing implant
- Compatible with MS Windows and Mac OS
- Import methods: external storage (USB) or retrieve from Scanner Workstation
- Supports computational modeling of: Medtronic Pipeline Flex Embolization Device (P100018/S015), Stryker Surpass Evolve Flow Diverter System (P170024/S003), Microvention Woven EndoBridge Aneurysm Embolism System (P170032)
- Version 1.0.6
- Functionalities: segmentation of neurovascular structures, automatic centerline detection, 2D/3D visualization of X-Ray images, placing and sizing tools, reporting tools
- Local openGL rendering
- Data transfer via physical media (USB) or Scanner Workstations (retrieve only)
- Uses Ansys solver for ID module (off-the-shelf), Sim&Cure Finite-Element (sacFE) solver (in-house) for intrasaccular devices
- Automatic and manual fusion correction
- No patient contact, prescription use only
Description
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 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. 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.