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Lutonix™
Lutonix™ 035 drug coated balloon PTA catheter for dysfunctional AV fistula
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5mm x 100mm - 75 cm long Lutonix™ AV Drug Coated Balloon
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- Overview
- Specifications
- eIFUs and Resources
- FAQ
- Product Notifications
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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First drug coated balloon approved for use in dysfunctional/stenosed hemodialysis fistulae in the U.S.
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Shown to enable longer AV fistula function due to increased time to first reintervention compared to standard angioplasty¹
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71.4% Primary Patency in the Lutonix AV IDE trial at 6 months¹
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31.3% fewer reinterventions than PTA at 6 months in the Lutonix AV IDE trail¹
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Demonstrated a safety profile that is as safe as PTA¹ʼ²Patients 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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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
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Demonstrated a safety profile that is as safe as PTA¹ʼ²Patients 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
GTIN - Each
00801741135378
1
Catheter Length
75 cm
Diameter
5
French Size
5F
Length
100
Rated Burst Pressure (atm)
12
GTIN
| GTIN - Each | 00801741135378 | 1 |
Product Basic Specification
| Catheter Length | 75 cm |
| Diameter | 5 |
| French Size | 5F |
| Length | 100 |
| Rated Burst Pressure (atm) | 12 |
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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
information quickly and effectively, please contact our customer complaints
team.
To better facilitate our investigation, please include the following information in your reporting:
- 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
- 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
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