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Lutonix™ 035 DCB
Dysfunctional AV Fistula Indication

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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.

    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

     

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    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 Clinical Studies

    Lutonix AV IDE Trial

    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.

    Lutonix AV Global Registry, AV Fistula Cohort 

    The Lutonix AV Global Registry was a prospective, multi-center, single-arm, real-world registry that assessed the safety and effectiveness of Lutonix™ 035 DCB in a real-world setting. 

    The Lutonix AV Fistula Cohort included subjects from the Lutonix AV Global Registry who met the Lutonix AV Trial eligibility criteria.

     

    Lutonix AV IDE Clinical Trial1

    Study Overview

    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.

    Primary Safety

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

     

    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. 

    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.

    Lutonix AV Global Registry, AV Fistula Cohort2

    Study Overview

    The Lutonix AV Global Registry was a prospective, multi-center, single-arm, real-world registry that assessed the safety and effectiveness of Lutonix™ 035 DCB in a real-world setting.

    The Lutonix AV Fistula Cohort included subjects from the Lutonix AV Global Registry who met the Lutonix AV IDE Trial eligibility criteria.

     

    Clinical Summary

    Primary Endpoints

    TLPP by Procedural Technique

    Patient Summary

    Target Lesion Location and Demographics

    12- Month Reintervention-Free Warranty

    Through the Lutonix™ 035 AV DCB Reintervention-Free Warranty Program, a replacement Lutonix™ 035 AV DCB is offered at no additional charge if a patient is treated with Lutonix™ 035 AV DCB, per the IFU for dysfunctional native AV dialysis fistulae, during the contract period, and returns for a reintervention of the original target lesion within 12 months of the initial treatment.*

    Clinical Resources

    Lutonix AV IDE Trial Brochure

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    Lutonix AV IDE vs. IN.PACT AV Access Trial Brochure

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    Lutonix AV Global Registry, AV Fistula Cohort Brochure

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    References

    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 (number at risk for primary safety endpoint was 144, number at risk for primary effectiveness endpoint was 144 at 6 months and 117 at 24 months).

    Post Hoc Analysis, Lutonix AV Fistula Cohort, a subset of the Lutonix AV Global Registry, which was a prospective, multi-center, single-arm registry that assessed the safety and effectiveness of the Lutonix™ 035 DCB in a real-world setting. N=124. Primary effectiveness endpoint was target lesion primary patency, defined as the interval following treatment until freedom from a clinically driven re-intervention of the target lesion or access thrombosis through 6 months, and is based on Kaplan Meier analysis with 92 subjects at risk. At 30 days, treatment with Lutonix™ 035 DCB was associated with freedom from primary safety event rate of 94.9%, with 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. Data on file. BD. Tempe, AZ.

    One limitation of the Lutonix AV Global Registry is that the subjects who met the Lutonix AV IDE eligibility criteria (the AV Fistula Cohort) are primarily White (49%) or Asian (46.9%) and thus are not entirely reflective of a U.S. patient population. Please consult product instructions for use for additional details.

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

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

     

    BD-144648 

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    Lutonix™ 035 DCB – Dysfunctional AV Fistula Indication BD Lutonix™ 035 drug coated balloon PTA catheter for dysfunctional AV fistula /content/dam/bd-assets/bd-com/en-us/logos/bd/header-bd-logo.svg DCB,Drug Coated Balloon,Drug Eluting Balloon,AV DCB,AV Fistula Indication,Paclitaxel,Angioplasty