RELATED PRODUCTS NOT AVAILABLE
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Lutonix™ 014 Drug Coated Balloon PTA Catheter
Below the Knee Drug Coated Balloon
- Overview
- Products & Accessories
- EIFU & Resources
The Lutonix™ 014 Below-the-Knee Drug Coated Balloon PTA Catheter is offered in 0.014 guidewire configurations. The Lutonix™ DCB delivers a dose of 2 µg/mm2 of paclitaxel and is designed to provide the versatility needed to treat lesions of varying sizes and lengths.
| Balloon Diameters | 2 - 4 mm |
| Balloon Lengths | 40 - 120 mm |
| Sheath Profile | 4F |
| Catheter Lengths | 150 cm |
The GeoAlign™ Marking System
The GeoAlign™ Marking System is a standardized non-radiopaque ruler on the catheter shaft designed to:
Facilitate repeat catheter placement
Increase procedural efficiency
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GeoAlign™ Markers are not a replacement for fluoroscopy. When the catheter is exposed to the vascular system, the location of the balloon should be confirmed while under high quality fluoroscopic observation. Animal study (repeat PTA in swine artery) was performed by 3 physicians who tested the Lutonix™ 035 DCB (no drug) and the Ultraverse™ 035 PTA Catheter, both with GeoAlign™ Markers, to POBA with no GeoAlign™ Markers (n=112, test n = 96, control n = 16). Animal data on file. BD Animal test results may not be indicative of clinical performance. Different test methods may yield different results.
Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information. ℞ only
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