Sapphire II NC Coronary Dilatation Catheter
Manufacturer
OrbusNeich® (The Netherlands)
Type
Non-Compliant PTCA Balloon Catheter
Intended Use
Designed for dilatation of stenotic regions in coronary arteries to improve myocardial perfusion.
Technical Specifications
- Catheter Type: Rapid Exchange
- Working Length: 140 cm
- Balloon Material: High-strength Nylon
- Balloon Diameter Range: 1.75 mm – 5.00 mm
- Balloon Lengths: 8 mm – 18 mm
- Nominal Pressure: approx. 12 atm
- Rated Burst Pressure (RBP): up to 20 atm (depending on size)
- Compliance: Controlled-Compliant (non-compliant balloon with precise expansion control)
- Balloon Folds: 3 folds (1.75–3.0 mm) / 5 folds (≥3.25 mm)
- Tip Design: Z-Tip with laser-welded joint for seamless transition and superior crossability
Regulatory Information
- CE Marked (EU MDR Class III Medical Device)
- Part of the Sapphire PTCA Family under OrbusNeich’s CE certification
- Commercially available across Europe, Asia, Australia & Africa
Key Features / Advantages
- Excellent crossability through tight or complex lesions
- Controlled expansion ensuring high precision and safety during inflation
- High pressure resistance with optimized nylon balloon and laser bonding technology
Precautions / Notes
- Not recommended for extremely calcified or tortuous lesions.
- Do not exceed the rated burst pressure to avoid balloon rupture.
- Single-use only. Must be used by trained interventional cardiologists under fluoroscopic guidance.
Conclusion
-
The Sapphire II NC Coronary Dilatation Catheter represents a new generation of non-compliant PTCA balloons that combines strength, precision, and flexibility. Its optimized Z-Tip design and high-pressure nylon balloon deliver superior crossability and controlled expansion, ensuring safe and effective lesion dilatation even in challenging coronary anatomies.
With CE certification and a proven clinical record of accomplishment, Sapphire II NC stands as a reliable choice for interventional cardiologists seeking consistent performance and procedural confidence.
* This information is provided for informational purposes only and is not intended to replace the product label. Please refer to the usage information accompanying each product to review its indications/purpose, contraindications, warnings, and precautions. Prescription only.
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