Sapphire II PRO Coronary Dilatation Catheter
Manufacturer
OrbusNeich® (The Netherlands)
Type
Semi-Compliant PTCA Balloon Catheter
Intended Use
- Designed for the dilatation of coronary artery or bypass graft stenosis to improve myocardial perfusion.
- For balloon sizes 1.25–4.0 mm, intended for the treatment of lesions associated with myocardial ischemia or acute myocardial infarction (AMI).
Technical Specifications
- Catheter Type: Rapid Exchange
- Working Length: 140 cm
- Proximal Shaft Diameter: 2.0F
- Distal Shaft Diameter: 2.4F–2.7F (depending on balloon size)
- Tip Length: 2.0–2.5 mm
- Balloon Material: Pebax
- Balloon Folds: 3 folds
- Compliance: Semi-Compliant
- Nominal Pressure: 6 atm
- Rated Burst Pressure (RBP): 14–16 atm depending on size
- Guidewire Compatibility: 0.014″
- Guide Catheter Compatibility: 5F
- Coating:
- Distal shaft: Hydrophilic coating (tip to wire exit)
- Inner lumen: Hydrophobic coating to reduce friction
Key Features / Advantages
- Excellent crossability and trackability in tortuous or calcified coronary anatomy.
- Optimized Sub-Zero Tip for smooth lesion entry and reduced vessel trauma.
- P-TECH shaft design provides superior torque and pushability.
- Dual coating system minimizes friction, enhancing maneuverability.
- Wide balloon size range (1.25–4.0 mm) to suit diverse lesion profiles.
- Reliable inflation control for consistent and safe dilatation.
Precautions / Notes
- Single-use sterile device.
- Avoid use in heavily calcified or extremely tortuous vessels.
- Do not exceed RBP to avoid balloon rupture or vessel injury.
- For professional use under fluoroscopic guidance only.
Regulatory Information
- FDA 510(k) Cleared (K173680)
- CE Marked under EU MDR (Class III Medical Device)
- Commercially available in Europe, the U.S., and Asia
Conclusion
The Sapphire II PRO is a next-generation semi-compliant PTCA balloon catheter engineered for precision, flexibility, and reliable performance across a wide spectrum of coronary interventions.
Its advanced shaft and coating technology ensure smooth navigation and controlled inflation, making it the go-to solution for interventional cardiologists seeking confidence and consistency during every procedure.
* 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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