Sim&Size is a medical imaging software designed to help clinicians visualize cerebral blood vessels and simulate the placement and sizing of neurovascular implantable devices for preoperative planning. It uses 3D images from rotational angiography to provide 3D reconstructions, automatic vessel segmentation, and tools for sizing and positioning implantable devices, supporting better planning of neurovascular interventions and surgeries.
Intended Use
Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. It allows computational modeling of neurointerventional device placement, including segmentation, centerline detection, 2D and 3D visualization, and sizing tools.
Technology
Sim&Size is a standalone software that processes 3D rotational angiography DICOM data to reconstruct vascular trees, providing modules for simulating different types of neurovascular implantable devices such as flow diverters, intrasaccular devices, stents, and coils. It supports 3D assessment including implant apposition, volume embolization, metal surface coverage, and other measurements.
Performance
Performance testing included software verification and validation, bench testing comparing device placement in silicone phantoms with simulation, and retrospective in vivo testing comparing actual cases with simulation results, demonstrating the device performs as intended with no new safety concerns.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/19/2024
4 months - 2
FDA Approval
12/14/2024
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