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Lutonix™ 035 DCB – Dysfunctional AV Fistula Indication

First drug coated balloon approved for use in dysfunctional/stenosed dialysis fistulae in the U.S.

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Overview
  • First drug coated balloon approved for use in dysfunctional/stenosed hemodialysis fistulae in the U.S.
  • Shown to enable longer AV fistula function due to increased time to first reintervention compared to standard angioplasty1
  • 71.4% Primary Patency in the Lutonix AV IDE trial at 6 months1
  • 31.3% fewer reinterventions than PTA at 6 months in the Lutonix AV IDE trail1
  • Demonstrated a safety profile that is as safe as PTA1,2
    • Patients in the Lutonix AV IDE trial experienced 322 reintervention-free days after treatment with Lutonix™ 035 DCB - 114 more days than patients treated with PTA1
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Features and Benefits
Time to Expect More

The Lutonix™ 035 DCB was shown to increase time to first reintervention compared to standard angioplasty.1

Largest Offering & Lowest Profile

The Lutonix™ 035 DCB has the broadest size offering of available AV DCBs in the U.S., with diameters up to 12mm and all sizes 5F- 7F*.

Optimized Formulation

The Lutonix™ formulation was designed for the optimal balance of safety and efficacy with a dose of 2 µg/mm2 and appropriate excipient, which together allow for effective transfer of drug to the vessel wall.

Lutonix™ AV IDE Clinical Trial

Study Synopsis

The AV Lutonix Clinical Trial was the first U.S. IDE trial approved by the FDA to evaluate the use of a DCB for the treatment of dysfunctional AV fistulae in 285 randomized patients. The primary objective of the Lutonix AV study was to demonstrate superior effectiveness and non-inferior safety of the Lutonix AV DCB Catheter, for treatment of dysfunctional AV fistulae located in the upper extremity, by direct comparison to uncoated PTA catheter.

Measurable Outcomes

Patency
Patency

Lutonix™ 035 DCB demonstrated improved primary patency compared to PTA at 24 months.

Reinterventions at 6 Months
Reinterventions at 6 Months
Reintervention Free Days
Reintervention Free Days

Lutonix™ 035 DCB was shown to lengthen the time to first reintervention compared to PTA.

Safety
Safety

Lutonix™ 035 DCB met the primary safety endpoint and demonstrated a safety profile that is as safe as PTA

 

Study Design & Procedure Summary
Study Design & Procedure Summary

    Study Design: Prospective, Global, Multicenter, Randomized, Core Lab Blinded, Safety, and Effectiveness


    Objective:
      To assess the safety and effectiveness of the Lutonix™ 035 AV Drug Coated balloon PTA Catheter in the treatment of dysfunctional AV fistulae


    Number of Patients/Sites:
      285 randomized subjects at 23 clinical sites


    Primary Effectiveness Endpoint:
    Target Lesion Primary Patency (TLPP) - 6 months


    Primary Safety Endpoint:
    Freedom from any serious adverse event(s) involving the AV access circuit through 30 days


    Follow up:
    1, 3, 6, 9, 12, 18, 24 months

Clinical Trial Procedure Summary
Clinical Trial Procedure Summary
Baseline Demographics

Both treatment arms were balanced with no significant differences in patient demographics

  • 69.5% of lesions were restenotic
  • 58.2% of patients were diabetic
  • 94.3% of patients were hypertensive
  • 58.9% of patients had cardiovascular disease
Fistula Locations
Fistula Locations
Target Lesion Location DCB (N=141) PTA (N=144)
Inflow 33.8% 29.6%
Outflow 24.5% 22.5%
Cephalic Arch 18.7% 22.5%
Swing Point 14.4% 12.0%
Cannulation Zone 4.3% 9.9%
Anastomotic 4.3% 3.5%

Study Synopsis

The primary objective of the Lutonix DCB AV Global Registry was to demonstrate safety and assess the clinical use and outcomes of the Lutonix® DCB for treatment of dysfunctional AVFs & AVGs located in the arm in a heterogeneous patient population in real world clinical practice.

Details

Primary Endpoints
Subgroups
Exploratory Subgroup Analysis: Procedural Details TLPP at 6 Months

VariableLevelTLPP at 6 MonthsP-ValueVessel PreparationYes77.0%0.0005No48.6%Inflation Time50-120 seconds67.9%0.0074120-180 seconds79.8%180-240 seconds75.0%

Reduced Patient Pain

 Patients who received Bard 3DMax™ Mesh without fixation used significantly less narcotic analgesia in the immediate postoperative period than those in whom flat mesh was fixated.2

Compatible with Various Laparoscopic Approaches
  • TAPP
  • TEP
  • Robotic TAPP
Primary Endpoints

Exploratory Subgroup Analysis: Procedural Details TLPP at 6 Months
Exploratory Subgroup Analysis: Procedural Details TLPP at 6 Months
Variable Level TLPP at 6 Months P-Value
Vessel Preparation Yes 77.0% 0.0005
  No 48.6%  
Inflation Time 50-120 seconds 67.9% 0.0074
  120-180 seconds 79.8%  
  180-240 seconds 75.0%  

Study Design and Procedure

Prospective, Multi-Center, Single-Arm, Real-World Registry

320 subjects with 391 lesions in 25 international centers

Demonstrate safety and assess the clinical use and outcomes of the Lutonix™ DCB for treatment of dysfunctional AVF's and AVG's located in the arm in a heterogeneous patient population in real-world clinical prcatice

AVF's and AVG's located in the arm, including central veins, presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines

  • ISR
  • De novo lesions
  • Restenotic lesions

  • 25% AVG's, 75% AVF's
  • Upper Arm: 47.5%
  • Lower Arm:41.3%

Target Lesion Primary Patency (TLPP) - 6 months

Freedom from any serious adverse event(s) involving the AV access circuit through 30 days

12 months

Baseline Characteristics

Baseline Characteristics  AV Registry

 N=320
Age (Years), Mean ± SD (n)
Median (Min, Max)
67.3 ± 12.8 (320)
69.0 (32.0, 90.0)
Gender, % (n/N)
Female 43.4% (139/320)
Male 56.6% (181/320)
Race, % (n/N)
 Asian 42.0% (102/243)
Black or African American 3.7% (9/243)
Other 2.1% (5/243)
  White 52.3% (127/243)
Any Diabetes, % 41.9% (134/320)
Dyslipidemia, % 26.9% (86/320)
Hypertension, %  73.4% (235/320)
Fistula Locations
Fistula Locations
Products & Accessories
  • product-image

    8mm x 60mm Lutonix™ AV Drug Coated Balloon

  • product-image

    9mm x 40mm - 100 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

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

  • product-image

    12mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    5mm x 60mm Lutonix™ AV Drug Coated Balloon

  • product-image

    10mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    5mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    12mm x 60mm - 100 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    5mm x 100mm Lutonix™ AV Drug Coated Balloon

  • product-image

    7mm x 60mm Lutonix™ AV Drug Coated Balloon

  • product-image

    5mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    12mm x 40mm - 100 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    7mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    9mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    8mm x 40mm - 100 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    6mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    6mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    7mm x 40mm Lutonix™ AV Drug Coated Balloon

  • product-image

    8mm x 40mm Lutonix™ AV Drug Coated Balloon

  • product-image

    4mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    7mm x 100mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    8mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    10mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    5mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    7mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    9mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    5mm x 40mm Lutonix™ AV Drug Coated Balloon

  • product-image

    10mm x 40mm - 100 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    9mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    8mm x 60mm - 100 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    7mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    8mm x 100mm - 100 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    8mm x 80mm - 100 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    8mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    6mm x 40mm Lutonix™ AV Drug Coated Balloon

  • product-image

    5mm x 80mm Lutonix™ AV Drug Coated Balloon

  • product-image

    6mm x 100mm Lutonix™ AV Drug Coated Balloon

  • product-image

    5mm x 100mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    8mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    9mm x 60mm - 100 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    4mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    8mm x 100mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    6mm x 100mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    6mm x 60mm Lutonix™ AV Drug Coated Balloon

  • product-image

    9mm x 80mm - 100 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    10mm x 60mm - 100 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    6mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    12mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon

  • product-image

    6mm x 80mm Lutonix™ AV Drug Coated Balloon

  • product-image

    4mm x 100mm - 75 cm long Lutonix™ AV Drug Coated Balloon

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

true
Resources
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

true
Frequently Asked Questions
false

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

true
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