Intended Use:
Providing precise renal access for PCNL (Percutaneous Nephrolithotomy) procedures under dual ultrasound/fluoroscopy guidance in patients with:
- Nephrolithiasis (kidney stones >2cm)
- Obstructive hydronephrosis
- Post-transplant nephrostomy requirements
- Complex calyceal anatomy cases
Key Clinical Advantages:
- 37% faster parenchymal penetration vs standard needles (in vitro testing)
- 62% reduction in needle deflection during deep access
- 360° fluoroscopic visibility even at 30° oblique angles
- Dual-tip technology for differentiated tissue penetration
Enhanced Product Features:
1. Smart-Tip Needle System
- 18G * 20cm diamond-cut trocar tip (0° penetration angle) for tough renal capsules
- Alternate beveled tip configuration (30° angle) for delicate parenchymal layers
- Proprietary sandblasting process increases radiopacity by 2.3x versus competitors
2. Precision Guidance Technology
- Laser-etched depth markers every 1mm with 0.2mm tolerance
- 3-tiered marker system:
- 5mm bands at critical depths (3cm/5cm/7cm)
- Micro-grooves for tactile feedback during advancement
- UV-reactive coating for endoscopic light conditions
3. Deflection-Resistant Shaft
- Nitinol core with tungsten reinforcement (0.003" tolerance)
- Spiral-cut distal 3cm for controlled flexibility
- Hydrophilic coating reduces tissue drag by 41%
Procedure-Specific Configurations Available:
- Standard Access Kit : 1 needle, coaxial dilator, 0.035" guidewire
- Advanced Stone Suite : Adds Amplatz sheath and stone basket
- Pediatric Mini-Kit : 20G * 15cm needle with 1cm markers
Quality Certifications:
- CE Marked (Class IIb Medical Device)
- ISO 13485:2016 Manufacturing
- Sterile EO processed (Validated 3-year shelf life)