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Lutonix™ 035 DCB
Dysfunctional AV Fistula Indication

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Lutonix AV displayed in human arm
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Overview

The 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 that are 4 mm to 12 mm in diameter and up to 80 mm in length.

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    Product Offering

    The GeoAlign™ Marking System

    The GeoAlign™ Marking System on the Lutonix™ 035 DCB is designed to facilitate repeatable catheter alignment at the lesion and increase procedural efficiency.1

     

    References

    Pressures are dependent on the size of the balloon diameters.

    The GeoAlign™ Marking System is not a replacement for fluoroscopy. The Lutonix™ 035 DCB should always be manipulated under fluoroscopic observation when in the body. Animal study (repeat PTA in swine artery) was performed by 3 physicians who tested the Lutonix™ 035 DCB (no drug) and the Ultraverse™ 035 PTA Catheter, both with GeoAlign™ Markers, to POBA with no GeoAlign™ Markers (n=112, test n=96 (average placement time of 66 seconds), control n=16 (average placement of 90 seconds)). Animal data on file, BD, Tempe AZ. Animal test results may not be indicative of clinical performance. Different test methods may yield different results.

    2 Dry Inflate/Shake Bench Test data on file. BD. Tempe, AZ. Shake test measured the average drug content lost after balloon was inflated, and after lightly knocking each device against the sides of the centrifuge tube, left and right, five times. n=5 for both devices tested. Bench test results may not be indicative of actual clinical performance. Different test methods may yield different results.

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

     

    BD-90919

    Lutonix AV IDE Clinical Study

    Clinical Summary

     

    The Lutonix AV IDE Trial was the first U.S. trial to evaluate the use of a DCB for the treatment of dysfunctional AV fistulas.1

    • LUT-AV_BDX-Webpage-Update_PIECHARTS-Primary-Safety(1).png
    • LUT-AV_BDX-Webpage-Update_PIECHARTS-TLPP(1).png
    • Card Image

    Primary Safety

    Lutonix™ 035 DCB met its primary safety endpoint and demonstrated a safety profile that is non-inferior in comparison to standard PTA.1

     

    Primary Patency

    At 6 months, treatment with the Lutonix™ 035 DCB resulted in a target lesion primary patency rate of 71.4% versus 63.0% with standard PTA. 1

    Reinterventions

    In the Lutonix AV IDE Trial at 24 months’ follow-up, patients treated with a Lutonix™ 035 DCB had gone an average of 321.8 days before first reintervention – 114 more days than patients treated with PTA alone.1

    12 - Month Reintervention-Free Warranty

    Click here to download clinical brochure

    english
    english

    References

    1 Lutonix AV IDE Trial. Data on file. BD. Tempe, AZ. At 6 months, treatment with Lutonix™ 035 DCB resulted in a target lesion patency rate of 71.4% versus 63.0% with standard PTA alone. Target lesion primary patency defined as freedom from 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. At 30 days, treatment with Lutonix™ 035 DCB was associated with 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. At 24 months' follow-up, the average days before first reintervention was found to be longer for patients treated with a Lutonix™ 035 DCB (321.8 vs. 207.4, p<0.0001).

    2  BD reserves the right to terminate this program at any time. Please note, Lutonix™ 035 AV DCB Reintervention Free Warranty Purchase Agreement terms and conditions apply.

    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 wihich is also 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 use for indications, contraindications, hazards, warnings and precautions. ℞ only

     

    BD-90919

    Products & Accessories
    • product-image

      Lutonix™ AV Drug Coated Balloon

      9mm x 40mm - 100 cm long 

    • product-image

      Lutonix™ AV Drug Coated Balloon

      4mm x 40mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      12mm x 40mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      10mm x 60mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      5mm x 40mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      12mm x 60mm - 100 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      12mm x 40mm - 100 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      5mm x 80mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      7mm x 80mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      9mm x 60mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      8mm x 40mm - 100 cm

    • product-image

      Lutonix™ AV Drug Coated Balloon

      6mm x 60mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      6mm x 80mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      4mm x 80mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      7mm x 100mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      8mm x 80mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      10mm x 40mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      5mm x 60mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      7mm x 60mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      9mm x 40mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      10mm x 40mm - 100 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      9mm x 80mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      8mm x 60mm - 100 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      7mm x 40mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      8mm x 100mm - 100 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      8mm x 80mm - 100 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      8mm x 40mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      5mm x 100mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      9mm x 60mm - 100 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      8mm x 60mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      4mm x 60mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      8mm x 100mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      6mm x 100mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      9mm x 80mm - 100 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      10mm x 60mm - 100 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      6mm x 40mm - 75 cm long

    • product-image

      Lutonix™ AV Drug Coated Balloon

      12mm x 60mm - 75 cm

    • product-image

      Lutonix™ AV Drug Coated Balloon

      4mm x 100mm - 75 cm long

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