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LUTONIX® with GEOALIGN®

LUTONIX® with GEOALIGN®
LUTONIX® 035 Drug Coated Balloon PTA Catheter | 5F

Angioplasty – Drug Coated Balloons

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Maximized Efficacy, Indisputable Safety

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.

LUTONIX® Drug Coated Balloon

LUTONIX® Drug Coated Balloon

Lowest Profile DCB*

The Lutonix® 035 DCB catheter is the only DCB with all offered sizes 5F, making it 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. Lutonix® 035 DCB 5F is available in the following sizes:

  • Lengths: 40, 60, 80, 100, 120, 150 mm
  • Diameter:4-6 mm up to 150 mm, 7 mm up to 60 mm
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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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Specifications

Product Item IDProduct Item NameBalloon Diameter (mm)Balloon LengthCatheter Length (cm)Sheath Size (F)Units/Each
LX3575440LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter length 4mm diameter x 40mm length4407551
LX3575460LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter length 4mm diameter x 60mm length 4607551
LX3575480LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter Length 4mm diameter x 80mm  length4807551
LX35754100LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter Length 4mm diameter x 100mm length 41007551
LX3575540LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter Length 5mm diameter x 40mm length 5407551
LX3575560LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter Length 5mm diameter x 60mm length 5607551
LX3575580LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter Length 5mm diameter x 80mm  length5807551
LX35755100LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter Length 5mm diameter x 100mm length 51007551
LX3575640LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter length 6mm diameter x 40mm length 6407561
LX3575660LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter Length 6mm diameter x 60mm length 6607561
LX3575680LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter Length 6mm diameter x 80mm length 6807561
LX35756100LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter Length 6mm diameter x 100mm  length61007561
LX3575740LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter 7mm x 40mm Balloon7407571
LX3575760LUTONIX® 035 Drug Coated Balloon PTA Catheter 75cm Catheter 7mm x 60mm Balloon7607571
LX35130440LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 4mm diameter x 40mm length 44013051
LX35130460LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 4mm diameter x 60mm length 46013051
LX35130480LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 4mm diameter x 80mm length48013051
LX351304100LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 4mm diameter x100mm length 410013051
LX351304120LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter 4mm x 120mm Balloon412013051
LX351304150LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter 4mm x 150mm Balloon415013051
LX35130540LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 5mm diameter x 40mm length 54013051
LX35130560LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 5mm diameter x 60mm length 56013051
LX35130580LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 5mm diameter x 80mm length 58013051
LX351305100LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 5mm diameter x100mm  length510013051
LX351305120LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter 5mm x 120mm Balloon512013051
LX351305150LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter 5mm x 150mm Balloon515013051
LX35130640LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 6mm diameter x 40mm  length64013061
LX35130660LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 6mm diameter x 60mm length 66013061
LX35130680LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 6mm diameter x 80mm  length68013061
LX351306100LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter Length 6mm diameter x100mm length 610013061
LX351306120LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter 6mm x 120mm Balloon612013061
LX351306150LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter 6mm x 150mm Balloon615013061
LX35130740LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter 7mm x 40mm Balloon74013071
LX35130760LUTONIX® 035 Drug Coated Balloon PTA Catheter 130cm Catheter 7mm x 60mm Balloon76013071
LX35754405FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x40mm 5 French4407551
LX35754605FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x60mm 5 French4607551
LX35754805FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x80mm 5 French4807551
LX357541005FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 4x100mm 5 French41007551
LX35755405FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x40mm 5 French5407551
LX35755605FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x60mm 5 French5607551
LX35755805FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x80mm 5 French5807551
LX357551005FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x100mm 5 French51007551
LX35756405FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x40mm 5 French6407551
LX35756605FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x60mm 5 French6607551
LX35756805FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x80mm 5 French6807551
LX357561005FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 6x100mm 5 French61007551
LX35757405FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x40mm 5 French7407551
LX35757605FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 7x60mm 5 French7607551
LX351304405FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x40mm 5 French44013051
LX351304605FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x60mm 5 French46013051
LX351304805FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x80mm 5 French48013051
LX3513041005FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x100mm 5 French410013051
LX3513041205FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x120mm 5 French412013051
LX3513041505FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x150mm 5 French415013051
LX351305405FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x40mm 5 French54013051
LX351305605FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x60mm 5 French56013051
LX351305805FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x80mm 5 French58013051
LX3513061005FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x100mm 5 French610013051
LX3513061205FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x120mm 5 French612013051
LX3513061505FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 6x150mm 5 French615013051
LX351307405FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x40mm 5 French74013051
LX351307605FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 7x60mm 5 French76013051
LX3513051005FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130 cm 5x100 mm 5 French510013051
LX3513051205FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130 cm 5x120 mm 5 French512013051
LX3513051505FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130 cm 5x150 mm 5 French515013051
LX351306405FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130 cm 6x40 mm 5 French64013051
LX351306605FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130 cm 6x60 mm 5 French66013051
LX351306805FLUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130 cm 6X80 mm 5 French68013051

*Lutonix® offered sizes as of March 2016: lengths of 40, 60, 80, 100, 120, 150 mm, diameters of 4-6 mm up to 150 mm, 7 mm up to 60 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.

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