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Lutonix™ Lutonix™ 035 drug coated balloon PTA catheter for dysfunctional AV fistula

4mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon

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Overview

 Lutonix™ 035 Drug Coated Balloon PTA Catheter is indicated for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistulae.

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Features and Benefits
Promotional Story
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References
  1. Lutonix™ AV Clinical Trial data on file. N=285. At 6 months, treatment with Lutonix™ 035 DCB resulted in a primary patency rate of 71.4% versus 63.0% with PTA alone. Primary patency defined as ending with a clinically driven re-intervention of the target lesion or access thrombosis. The primary effectiveness analysis for superiority of DCB vs. PTA was not met with a one sided p-value of p = 0.0562. Number of interventions required to maintain TLP at 6 months were 44 in DCB arm versus 64 in the PTA arm. At 30 days, treatment with Lutonix™ 035 resulted in a freedom from primary safety event rate of 95.0% versus 95.8% with PTA alone. Primary safety defined as freedom from localized or systemic serious adverse events through 30 days that reasonably suggests the involvement of the AV access circuit. The primary safety endpoint for noninferiority for DCB vs. PTA was met with one-sided p-value of p = 0.0019. Percentages reported are derived from Kaplan-Meier analyses. Mean time to TLPP event for subjects with an event was longer for DCBs (321.8 vs. 207.4 d; p<.0001).
  2. Bench testing showed that the Lutonix™ 035 catheter’s drug coating varied on average up to +- 5.1% per balloon segment relative to total balloon drug coating ratio. Data on file, Bard Peripheral Vascular, Inc. Different test methods may yield different results.
  3. Pre-clinical animal data on file. Animal test results may not be indicative of clinical performance. Different test methods may yield different results. Bard Peripheral Vascular, Inc., Tempe, AZ.
    *As of October 2021


Lutonix™ 035 Drug Coated Balloon PTA Catheter Indications for Use: The Lutonix™ Catheter is indicated for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for treatment of stenotic lesions of dysfunctional native arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80 mm in length.

Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information. ℞ only

BD-23451

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Specification

GTIN - each

00801741135309

1


Catheter Length

75 cm

Diameter

4

French Size

5F

Length

40

Rated Burst Pressure (atm)

12

GTIN

GTIN - each 00801741135309 1

Product Basic Specification

Catheter Length 75 cm
Diameter 4
French Size 5F
Length 40
Rated Burst Pressure (atm) 12
References
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Electronic Instructions for Use (eIFUs)
Resources
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Frequently Asked Questions
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Alternatives Comparison
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    • Product Name
    • For Use With
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    • Length
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    • Product Name
    • For Use With
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    • For Use With
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    • Diameter
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  • Product Image
    • Product Name

      4mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon
    • For Use With

      NA
    • Gauge Size

      NA
    • Shape

      NA
    • MRI Compatible

      NA
    • Length

      40
    • Catheter Length

      75 cm
    • Material

      NA
    • Needle Length

      NA
    • Rated Burst Pressure (atm)

      12
    • Diameter

      4
    • French Size

      5F
  • Product Image
    • Product Name

      UltraClip™ II Breast Tissue Marker - Coil Shape made of BioDur™ 108
    • For Use With

      Independently or through coaxial
    • Gauge Size

      17
    • Shape

      Coil
    • MRI Compatible

      No
    • Length

      NA
    • Catheter Length

      NA
    • Material

      BioDur™ 108
    • Needle Length

      10 cm
    • Rated Burst Pressure (atm)

      NA
    • Diameter

      NA
    • French Size

      NA
Related Products
RELATED PRODUCTS NOT AVAILABLE
References
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Product Complaints
North American Regional Complaint Center
1-844-8BD-LIFE (1-844-823-5433)
Things to Consider

If you are a patient or end user, you can contact us yourself, or you may have your caregiver or your physician do that for you. To help us process your
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  • Product Name and/or Catalog Number
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  • Is the actual sample or sample representative available? (If possible, please send affected sample)
  • Contact name and phone number
References
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