Product overviewKrystoLens is the first disposable 3D neuro-endoscope featuring a wide-angle surgical working channel for cranial surgery visualization. It supports diagnostic and therapeutic procedures including ventriculostomy, biopsy guidance, cyst and tumor removal, and management of intracranial obstructions.
Clinical indications- Endoscopic visualization for ventriculostomy
- Biopsy guidance
- Removal of cysts and tumors
- Management of other intracranial obstructions
Regulatory statusKrystoLens is under development. Planned submissions: TFDA in early 2025 and FDA and CE around 2026.
Product components and descriptions- KrystoLens endoscope / sheath: Dual-lens design providing true 3D view during endoscopic surgery; includes an irrigation channel for rapid lens cleansing during procedures; working channel dimensions: 8.5 mm × 4.7 mm.
- KrystoLens obturator: Protects tissue during sheath insertion; includes a stainless steel rod compatible with intraoperative C-arm/X-ray scanning.
- KrystoLens TV Box: Compact TV box (approx. 140 mm × 140 mm) to save operating room space; 3D compatibility and HDMI output for display integration.
Key features- Disposable 3D neuro-endoscope with wide-angle working channel
- Dual-lens 3D visualization for improved depth perception
- Integrated irrigation channel for rapid lens cleansing
- Working channel size: 8.5 mm × 4.7 mm
- Single-use, sealed and ethylene oxide (EO) sterilized
- Crystal-clear working channel with wide field of view
- Plug-and-play, hands-free installation to save time and space
- Compatible with surgical robots for high-precision procedures
- Obturator stainless steel rod suitable for intraoperative X-ray/C-arm use
- Compact TV box with 3D display capability and HDMI output; recommended integration with 4K medical-grade monitors
Technical specifications- Device type: Disposable 2D/3D neuro-endoscope (3D-capable, dual-lens)
- Working channel dimensions: 8.5 mm × 4.7 mm
- Irrigation channel: integrated for lens cleansing
- Design: Single-use, sealed and EO sterilized
- Obturator: stainless steel rod for insertion protection and X-ray compatibility
- TV Box size: approx. 140 mm × 140 mm; 3D compatibility; HDMI output
- Display recommendation: 43-inch 4K medical-grade monitor (3D-capable)
- Intended procedures: ventriculostomy, biopsy, cyst/tumor removal, other intracranial obstruction management
- Regulatory submission timeline: TFDA early 2025; FDA and CE around 2026