Reach for the AV DCB With the Largest Size Offering
The Lutonix™ 035 DCB, the first DCB indicated for AV fistulae, is available in 4 new sizes, and several profiles have been reduced, keeping the entire product offering at or below 7F, even up to 12mm diameters. Lutonix™ 035 enabled longer AV fistulae function by reducing reinterventions by 31.3% at 6 months, and at 24 months, patients who were treated with a Lutonix DCB went an average of 322 days before needing a reintervention compared to 207 days when treated with PTA alone.
Balloon Length (mm)
4 5 6 7 8 9
10 12
40 60 80 100 5F 5F 5F 5F 6F 7F 7F 7F
5F 5F 5F 5F 6F 7F 7F 7F
Bold = New Sizes Other Blue Boxes = Reduced Profiles
5F 5F 5F
5F 5F 5F
5F 5F 6F 6F 7F
Reintervention in the Lutonix AV IDE Trial*
Days to First 322
* Lutonix™
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. Mean time to TLPP event for subjects with an event was longer for DCBs (321.8 vs. 207.4 d; p< .0001). Percentages reported are derived from Kaplan-Meier analyses. Lutonix Global AV Registry data on file. N=320. At 6 months, treatment with Lutonix™ Global AV Registry on file. N=320. By access type, treatment with Lutonix™
intervention until clinically driven reintervention of the target lesion or access thrombosis. Percentages reported are estimated based on Kaplan-Meier estimates.
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 that are 4 mm to 12 mm in diameter and up to 80 mm in length. Please consult product labels and instructions for indications, contraindications, hazards, warnings, and precautions.
The Lutonix™
AV Clinical Trial data on file. N=285. At 6 months, treatment with Lutonix™
035 DCB resulted in a TLPP of 78.1% for native fistulas only (240/320) and 61.9% for synthetic (graft) only (80/320). TLPP defined as the interval following index procedure
035 AV 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 035 DCB resulted in a target lesion primary patency (TLPP) rate of 73.9%. Lutonix
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© 2021 BD. BD, the BD Logo, and Lutonix are trademarks of Becton, Dickinson and Company or an affiliate. Illustrations by Mike Austin. Copyright 2021. All Rights Reserved. BD-16426
Balloon Diameter (mm)
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