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Products

Lutonix™ 035 Drug Coated Balloon PTA Catheter

Angioplasty – Drug Coated Balloons.

 

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Overview

The Lutonix™ Drug Coated Balloon PTA Catheter is offered in 0.018” and 0.035” guidewire configurations for the treatment of peripheral arterial disease in the superficial femoral and popliteal arteries.  The Lutonix™ DCB delivers 2 µg/mm2 of paclitaxel and is designed to provide the versatility needed to treat lesions of varying sizes and lengths.  It is engineered to enhance femoropopliteal procedures by providing:

  • A robust size matrix
  • Extensive indications
  • Proven results in a Level 1 Clinical Trial1
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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*

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

Reference

*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

Reference

*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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Reference

*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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