First and Only DCB With 018" and 035" Wire Configurations


* LONGEST


LENGTHS UP TO 300 MM


LOWEST CROSSING PROFILE


OFFERING


The Lutonix™ Drug Coated Balloon PTA Catheter is offered in both 0.035" and 0.018" wire configurations for the treatment of peripheral arterial disease in the superficial femoral and popliteal arteries.


ROBUST SIZE


Warnings: 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 package insert for more detailed safety information and instructions for use.


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BD, Tempe, AZ, USA, 1 800 321 4254 BD, the BD Logo, and Lutonix are trademarks of Becton, Dickinson and Company or its affiliates. © 2021 BD. Illustrations by Mike Austin © 2021. All Rights Reserved. BD-15575


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