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Lutonix™ with GEOALIGN®

Lutonix™ with GEOALIGN®
Lutonix™ 035 Drug Coated Balloon PTA Catheter

Angioplasty – Drug Coated Balloons.

 

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Features

  • Maximized Efficacy, Indisputable Safety
  • Lowest Profile DCB*
  • Increased Procedure Efficiency with GeoAlign™

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 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
lutonix-lowest-profile-dcb-details-2.jpg

lutonix-lowest-profile-dcb-details-2.jpg

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.**

lutonix-geoalign-details-3.jpg

lutonix-geoalign-details-3.jpg

For IFU please visit: http://www.bardpv.com/Lutonix035-IFU.php 

Specifications

Product Item IDProduct Item NameBalloon Diameter (mm)Balloon LengthCatheter Length (cm)Sheath Size (F)Units/Each.1
LX35754405FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 4x40mm 5F4407551
LX35754605FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 4x60mm 5F4607551
LX35754805FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 4x80mm 5F4807551
LX357541005FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 4x100mm 5F41007551
LX35755405FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 5x40mm 5F5407551
LX35755605FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 5x60mm 5F5607551
LX35755805FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 5x80mm 5F5807551
LX357551005FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 5x100mm 5F51007551
LX35756405FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 6x40mm 5F6407551
LX35756605FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 6x60mm 5F6607551
LX35756805FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 6x80mm 5F6807551
LX357561005FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 6x100mm 5F61007551
LX35757405FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 7x40mm 5F7407551
LX35757605FLutonix® 035 Drug Coated Balloon PTA Catheter 75cm 7x60mm 5F7607551
LX351304405FLutonix® 035 Drug Coated Balloon PTA Catheter 130mm 4x40mm 5F44013051
LX351304605FLutonix® .035in. 5F Drug Coated Balloon 130cm 4x60mm46013051
LX351304805FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 4x80mm 5F48013051
LX3513041005FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 4x100mm 5F410013051
LX3513041205FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 4x120mm 5F412013051
LX3513041505FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 4x150mm 5F415013051
LX3513042205F422013051
LX351305405FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 5x40mm 5F54013051
LX351305605FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 5x60mm 5F56013051
LX351305805FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 5x80mm 5F58013051
LX3513051005FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 5x100mm 5F510013051
LX3513051205FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 5x120mm 5F512013051
LX3513051505FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 5x150mm 5F515013051
LX3513052205F522013051
LX351306405FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 6x40mm 5F64013051
LX351306605FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 6x60mm 5F66013051
LX351306805FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 6x80mm 5F68013051
LX3513061005FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 6x100mm 5F610013051
LX3513061205FLutonix® 035 Drug Coated Balloon PTA Catheter130cm 6x120mm 5F612013051
LX3513061505FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 6x150mm 5F615013051
LX3513062205F622013051
LX351306220622013061
LX351307405FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 7x40mm 5F74013051
LX351307605FLutonix® 035 Drug Coated Balloon PTA Catheter 130cm 7x60mm 5F76013051
LX351307805F78013051
LX3513078078013061
LX3513071005F710013051
LX351307100710013061
LX3513071205F712013051
LX351307120712013061
LX3513071505F715013051
LX351307150715013061
LX3513072205F722013051
LX351307220722013061

*Lutonix offered sizes as of August 2018: 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.

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