Sapphire II PRO 1.0 mm
Manufacturer
OrbusNeich® (The Netherlands)
Type
Micro PTCA Balloon – Semi-Compliant
Intended Use
- Designed specifically for pre-dilatation of tight or complex coronary lesions (≥70% stenosis) and micro-vessel interventions where extremely small balloon diameters are required.
Technical Specifications
- Balloon Diameter: 1.0 mm
- Balloon Lengths: 6, 8, 10, 12 mm
- Working Length: 140 cm
- Catheter Type: Rapid Exchange
- Proximal Shaft Diameter: 1.9F
- Distal Shaft Diameter: 2.36F
- Tip Length: 1.5 mm
- Balloon Material: Nylon
- Balloon Folds: 2 folds
- Compliance: Semi-Compliant
- Nominal Pressure: 6 atm
- Rated Burst Pressure: 14 atm
- Coating: Hydrophilic (distal shaft) + hydrophobic inner lumen
- Guidewire Compatibility: 0.014″
- Guide Catheter Compatibility: 5F
Key Features / Advantages
- Ultra-low profile (1.0 mm balloon) for crossing highly stenotic or micro-vessels.
- Excellent flexibility and controlled inflation for safe lesion preparation.
- Reinforced shaft design ensures smooth trackability in tortuous anatomy.
- Z-tip design for minimal vessel trauma and improved access.
Regulatory Information
- FDA 510(k) Cleared (K173680)
- CE Marked under EU MDR
- Class III Medical Device
Conclusion
The Sapphire II PRO 1.0 mm micro-balloon catheter delivers exceptional performance in challenging coronary anatomies.
Its ultra-small profile and superior flexibility make it the ideal tool for pre-dilatation and initial lesion access where precision and safety are critical.
A reliable choice for interventional cardiologists seeking maximum control in the most delicate procedures.
* 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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