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LUTONIX® 018 Drug Coated Balloon PTA Catheter

LUTONIX® 018 Drug Coated Balloon PTA Catheter
LUTONIX® 018 Drug Coated Balloon PTA Catheter

Deliver More with the Only 018 DCB*

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Features

The LUTONIX® 018 DCB is designed to:

  • Perform over small guidewires (up to .018”)
  • Reduce guidewire exchanges
  • Enable alternative access

Built on the proven ULTRAVERSE™ 018 platform, LUTONIX® 018 features:

  • Enhanced Pushability – Reinforced inner lumen provides axial strength
  • Improved Visibility – Larger, dual distal marker bands on long lengths
  • GeoAlign® Marking System – Facilitates simple repeat catheter alignment at the lesion

With a crossing profile 20% lower than the lowest profile 035 DCB1, LUTONIX® 018 was built to:

  • Cross tight lesions
  • Navigate tortuous anatomy
  • Reliably deliver drug to complex lesions

The LUTONIX® 018 DCB utilizes the same proven drug coating formulation as the LUTONIX® 035 DCB, which demonstrated outstanding 24 month freedom from TLR in the following patient groups2

  • ISR Subgroup: 84.6%
  • Long Lesion Subgroup: 88.2%
  • All Patients: 90.3%
LUTONIX® 018 Drug Coated Balloon PTA Catheter

LUTONIX® 018 Drug Coated Balloon PTA Catheter

Specifications

Product Item IDProduct Item NameDiameter (mm)Length (mm)Catheter Length (cm)
LX181004404FLutonix .018" DCB 100cm 4x40mm440100
LX1810041504FLutonix .018" DCB 100cm 4x150mm4150100
LX1810042204FLutonix .018" DCB 100cm 4x220mm4220100
LX181005405FLutonix .018" DCB 100cm 5x40mm540100
LX1810051505FLutonix .018" DCB 100cm 5x150mm5150100
LX1810052205FLutonix .018" DCB 100cm 5x220mm5220100
LX181006405FLutonix .018" DCB 100cm 6x40mm640100
LX1810061505FLutonix .018" DCB 100cm 6x150mm6150100
LX1810062205FLutonix .018" DCB 100cm 6x220mm6220100
LX181007405FLutonix .018" DCB 100cm 7x40mm740100
LX1810071505FLutonix .018" DCB 100cm 7x150mm7150100
LX181304404FLutonix .018" DCB 130cm 4x40mm440130
LX181304604FLutonix .018" DCB 130cm 4x60mm460130
LX181304804FLutonix .018" DCB 130cm 4x80mm480130
LX1813041004FLutonix .018" DCB 130cm 4x100mm4100130
LX1813041504FLutonix .018" DCB 130cm 4x150mm4150130
LX1813042204FLutonix .018" DCB 130cm 4x220mm4220130
LX181305405FLutonix .018" DCB 130cm 5x40mm540130
LX181305605FLutonix .018" DCB 130cm 5x60mm560130
LX181305805FLutonix .018" DCB 130cm 5x80mm580130
LX1813051005FLutonix .018" DCB 130cm 5x100mm5100130
LX1813051505FLutonix .018" DCB 130cm 5x150mm5150130
LX1813052205FLutonix .018" DCB 130cm 5x220mm5220130
LX181306405FLutonix .018" DCB 130cm 6x40mm640130
LX181306605FLutonix .018" DCB 130cm 6x60mm660130
LX81306805FLutonix .018" DCB 130cm 6x80mm680130
LX1813061005FLutonix .018" DCB 130cm 6x100mm6100130
LX1813061505FLutonix .018" DCB 130cm 6x150mm6150130
LX1813062205FLutonix .018" DCB 130cm 6x220mm6220130
LX181307405FLutonix .018" DCB 130cm 7x40mm740130
LX181307605FLutonix .018" DCB 130cm 7x60mm760130
LX181307805FLutonix .018" DCB 130cm 7x80mm780130
LX1813071005FLutonix .018" DCB 130cm 7x100mm7100130
LX1813071505FLutonix .018" DCB 130cm 7x150mm7150130
LX1813072205FLutonix .018" DCB 130cm 7x220mm7220130

Related Products

LUTONIX® 035 DCB – Dysfunctional AV Fistula Indication

LUTONIX® 035 DCB – Dysfunctional AV Fistula Indication

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1. Data on file. Bard Peripheral Vascular, Inc. Tempe, AZ. 4 x 220 mm LUTONIX® 035 DCB N=25, 4 x 220 LUTONIX® 018 DCB N = 30. Bench test results may not necessarily be indicative of clinical performance. Different tests may yield different results.

2. Primary efficacy endpoint is defined as freedom from TLR at 12 months. Total of 648 subjects were evaluable for the primary efficacy endpoint analysis. The 12 month TLR Free rate by subject counts at 12 months was 93.4%. The Kaplan-Meier estimates TLR-Free survival was 94.1% at 12 months and 90.3% at 24 months. TLR-Free survival by lesion location was 94.7% (n=483) for SFA, 92.9% (n=86) for popliteal, and 92.3% (n=121) for patients with lesions in both SFA and popliteal. Data on file, Bard Peripheral Vascular, Inc.

*As of December 2018; on the US market

 

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