Visualase V2 MRI-guided Laser Ablation System (9736422)
Medtronic NavigationThe Visualase V2 MRI-Guided Laser Ablation System is a neurosurgical tool designed to ablate, necrotize, or coagulate brain tissue including tumors and epileptic foci, using a laser controlled and monitored in real-time via MRI thermometry. It helps clinicians precisely target and treat affected brain areas in adults and pediatric patients aged 2 years and older.
Intended Use
Indicated to ablate, necrotize, or coagulate intracranial soft tissue including brain structures for brain tumor, radiation necrosis, epileptic foci in pediatric and adult patients aged 2 years and older.
Technology
The system consists of an energy source diode laser (980 nm wavelength), a saline-cooling pump, and a workstation with software that interfaces with MRI scanners to provide real-time thermal monitoring and controlled laser output via an interactive graphical user interface.
Performance
Testing demonstrated the device meets all design requirements and user needs. Software verification and validation, system verification, electrical safety, and applicable standards compliance were conducted. Clinical trials were not required; literature supports safe use in intended populations.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/3/2025
3 months - 2
FDA Approval
5/29/2025
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