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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The Lutonix™ DCB delivers a dose of 2 µg/mm of paclitaxel and is designed to provide the versatility needed to treat lesions of varying sizes and lengths.
Recommended Guidewire 0.035"
| Balloon Diameters | 4-12 mm |
| Balloon Lengths | 40-100 mm |
| Catheter Lengths | 75 cm |
| Rated Burst Pressure | 10-12 atm * |
| Nominal Pressure | 6, 7 atm * |
- Lutonix™ AV Clinical Trial data on file. N=285. At 6 months, treatment with Lutonix™ 035 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 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. At 30 days, treatment with Lutonix™ 035 resulted 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 noninferiority 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 DCBs (321.8 vs. 207.4 d; p<.0001)
- 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 Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information. ℞ only
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
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Lutonix™ 035 DCB met its primary safety endpoint and demonstrated a safety profile that is non-inferior in comparison to standard PTA.
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.
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
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.
Target Lesion Location and Demographics
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 (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).
2 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.
3 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.
Please consult product labels and instructions for use for indications, contraindications, hazards, warnings and precautions. ℞ only
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