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

8mm x 60mm - 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
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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

00801741135460

1


Catheter Length

75 cm

Diameter

8

French Size

6F

Length

60

Rated Burst Pressure (atm)

10

GTIN

GTIN - each 00801741135460 1

Product Basic Specification

Catheter Length 75 cm
Diameter 8
French Size 6F
Length 60
Rated Burst Pressure (atm) 10
References
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Electronic Instructions for Use (eIFUs)
Resources
References
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Frequently Asked Questions
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References
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Related Products
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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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References
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