Products- 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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Lutonix™ 035 DCB – Dysfunctional AV Fistula Indication
First drug coated balloon approved for use in dysfunctional/stenosed dialysis fistulae in the U.S.
- Overview
- Clinical Trial
- Global Registry
- Products & Accessories
- EIFU & Resources
- FAQ
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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.
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
Lutonix™ 035 DCB demonstrated improved primary patency compared to PTA at 24 months.
Reinterventions at 6 Months
Reintervention Free Days
Lutonix™ 035 DCB was shown to lengthen the time to first reintervention compared to PTA.
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: 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
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
| 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% |
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.
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
| 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 | 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
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8mm x 60mm Lutonix™ AV Drug Coated Balloon
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9mm x 40mm - 100 cm long Lutonix™ AV Drug Coated Balloon
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4mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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12mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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5mm x 60mm Lutonix™ AV Drug Coated Balloon
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10mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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5mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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12mm x 60mm - 100 cm long Lutonix™ AV Drug Coated Balloon
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5mm x 100mm Lutonix™ AV Drug Coated Balloon
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7mm x 60mm Lutonix™ AV Drug Coated Balloon
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5mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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12mm x 40mm - 100 cm long Lutonix™ AV Drug Coated Balloon
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7mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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9mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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8mm x 40mm - 100 cm long Lutonix™ AV Drug Coated Balloon
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6mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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6mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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7mm x 40mm Lutonix™ AV Drug Coated Balloon
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8mm x 40mm Lutonix™ AV Drug Coated Balloon
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4mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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7mm x 100mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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8mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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10mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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5mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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7mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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9mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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5mm x 40mm Lutonix™ AV Drug Coated Balloon
-
10mm x 40mm - 100 cm long Lutonix™ AV Drug Coated Balloon
-
9mm x 80mm - 75 cm long Lutonix™ AV Drug Coated Balloon
-
8mm x 60mm - 100 cm long Lutonix™ AV Drug Coated Balloon
-
7mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon
-
8mm x 100mm - 100 cm long Lutonix™ AV Drug Coated Balloon
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8mm x 80mm - 100 cm long Lutonix™ AV Drug Coated Balloon
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8mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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6mm x 40mm Lutonix™ AV Drug Coated Balloon
-
5mm x 80mm Lutonix™ AV Drug Coated Balloon
-
6mm x 100mm Lutonix™ AV Drug Coated Balloon
-
5mm x 100mm - 75 cm long Lutonix™ AV Drug Coated Balloon
-
8mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon
-
9mm x 60mm - 100 cm long Lutonix™ AV Drug Coated Balloon
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4mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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8mm x 100mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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6mm x 100mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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6mm x 60mm Lutonix™ AV Drug Coated Balloon
-
9mm x 80mm - 100 cm long Lutonix™ AV Drug Coated Balloon
-
10mm x 60mm - 100 cm long Lutonix™ AV Drug Coated Balloon
-
6mm x 40mm - 75 cm long Lutonix™ AV Drug Coated Balloon
-
12mm x 60mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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6mm x 80mm Lutonix™ AV Drug Coated Balloon
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4mm x 100mm - 75 cm long Lutonix™ AV Drug Coated Balloon
- 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).
- 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.
- 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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- 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).
- 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.
- 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
false
- 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).
- 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.
- 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