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Lutonix™ 035 Drug Coated Balloon PTA Catheter

Angioplasty – Drug Coated Balloons.

 

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Features

  • Maximized Efficacy
  • Lowest Profile DCB on the U.S. Market*
  • Increased Procedure Efficiency with GeoAlign™
Features and Benefits
Maximized Efficacy
The Lutonix™ DCB catheter is a drug-coated balloon catheter that delivers paclitaxel to the arterial wall in a single, short inflation. Paclitaxel is an anti-proliferative drug commonly used to prevent arterial restenosis. The Lutonix™ DCB’s highly efficient formulation of paclitaxel and carriers, polysorbate and sorbitol, allows Lutonix™ DCB catheter to deliver a therapeutic dose to the artery wall, while keeping the dose of paclitaxel on the balloon as low as possible.
Lowest Profile DCB*

The Lutonix™ 035 DCB catheter is the lowest profile DCB on the U.S. market.* This platform is designed to minimize the size of the access site, while maintaining an ease-of-use characteristic similar to PTA. 

  • Lengths: 40, 60, 80, 100, 120, 150, 220 mm
  • Diameters: 4-7 mm
Increased Procedure Efficiency with GeoAlign™
The Lutonix™ DCB features the GeoAlign™ Marking System. GeoAlign™ Markers serve as a simple-to-use, non-radiopaque ruler on the catheter shaft. The GeoAlign™ System is featured on both the Ultraverse™ 035 PTA Catheter and Lutonix™ 035 DCB. The GeoAlign™ System is designed to facilitate repeatable catheter alignment at the lesion and increase procedure efficiency by minimizing fluoroscopy exposure.**
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*Lutonix™ 035 DCB offered sizes as of November 2020: lengths of 40, 60, 80, 100, 120, 150. 220mm, diameters of 4-7 mm up to 220 mm

**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. Bard. 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

BD-23450

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