Reach for the Only AV DCB


Backed by a 12-Month Reintervention-Free Warranty


BD is proud to back Lutonix™


DCB, per the IFU for dysfunctional native AV dialysis fist turns for a


Catheter, the only AV DCB supported by an IDE trial and a global registry, with a 12-month reintervention-free warranty.y. Under the warranty, if you treat a patient with LutonixLut nix 035 ialysis fistulae,


035 Drug Coated Balloon PTA E t -f


™ 35


during the contract period, and that patient re urns f reintervention of the original target lesion within 1hin 12 months of the initial treatment, then a no charge rep acemen code will be sent to your account.


pllacement Contact your local BD sales representative for mor details more details. TA


Mean Time to First Reintervention in the Lutonix AV IDE Trial


rial


Standard PTA Lutonix™


100 207 Days 035 DCB FREE DAEE DAYS 200 BD reserves the right to terminate this mentioned program at any time. Please note, signed Lutonix™


Reintervention Free Warranty Purchase Agreement terms and conditions apply. Lutonix™


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 meaning the DCB arm required 31.3% fewer interventions. At 30 days, treatment with Lutonix™


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 non-inferiority 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 the Lutonix™


035 DCB (321.8 vs. 207.4 d; p<.0001).


Karnabatidis D, Kitrou PM, Ponce P, Chong TT, Pietura R, Pegis JD, Ko PJ, Lin CH; Lutonix AV Global Registry Investigators. A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results. J Vasc Interv Radiol. 2021 Mar;32(3):360-368.e2. doi: 10.1016/j.jvir.2020.11.018. Epub 2021 Jan 23. PMID: 33495064.


035 resulted AV Clinical Trial data on file. N=285. At 6 months, treatment with Lutonix™ 322 Days 2 Days


114 MORE REINTERVENTION ORE REINTERVENTION


300 035 AV DCB 035 DCB resulted in a target lesion primary 300 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.


Contraindications: 1) Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children over the next 2 years. It is unknown whether paclitaxel will be excreted in human milk and there is a potential for adverse reaction in nursing infants from paclitaxel exposure. 2) Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.


Warning: A signal for increased risk of late mortality has been identified following the use of paclitaxel-coated balloons and paclitaxel-eluting stents for femoropopliteal arterial disease beginning approximately 2-3 years post-treatment compared with the use of non-drug coated devices. There is uncertainty regarding the magnitude and mechanism for the increased late mortality risk, including the impact of repeat paclitaxel device exposure. Inadequate information is available to evaluate the potential mortality risk associated with the use of paclitaxel-coated devices for the treatment of other diseases/conditions, including this device indicated for use in arteriovenous dialysis fistulae. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options with their patients.


Please consult product labels and instructions for indications, contraindications, hazards, warnings, and precautions.


ention


bd.com BD, Tempe, AZ, USA, 1 800 321 4254


BD, the BD logo, and Lutonix are trademarks of Becton, Dickinson and Company or its affiliates. © 2022 BD. All rights reserved. © 2022 Illustration by Mike Austin. BD-49311


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