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- Overview
- Features
- Clinical Data
- EIFU & Resources
The Lutonix™ Drug Coated Balloon PTA Catheter is offered in 0.014” and 0.035” guidewire configurations for the treatment of peripheral arterial disease in the superficial femoral and popliteal arteries. The Lutonix™ DCB delivers a dose of 2 µg/mm2 of paclitaxel and is designed to provide the versatility needed to treat lesions of varying sizes and lengths. It is engineered to enhance femoropopliteal procedures by providing:
- A robust size matrix
- Extensive indications
- Proven results in a Level 1 Clinical Trial1
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Low drug dose:
Optimal drug dose of 2 μg/mm2 of paclitaxel
Tapered tip:
Designed to facilitate advancement of the catheter to and through the stenotic region of the vessel.
Low sheath profile:
5F or less
Durable coating:
Designed to limit drug flaking during preparation and handling
Balloon lengths up to 300 mm on select 0.018 sizes
Only 300 mm DCB available in the U.S.2
100 cm and 130 cm catheter length:
To accommodate your preferred access site
0.018 and 0.035 guidewire compatibility:
To support your treatment algorithm
The GeoAlign™ Marking System is a standardized non-radiopaque ruler on the catheter shaft designed to:
- Facilitate repeat catheter placement
- Increase procedural efficiency
- LEVANT 2 clinical trial data on file. N=476. At 12 months, treatment with Lutonix™ 035 resulted in a primary patency rate of 73.5% versus 56.8% with PTA alone (p=0.001). Primary patency defined as absence of binary restenosis defined by DUS PSVR ≥ 2.5 and freedom from Target Lesion Revascularization (TLR). At 12 months, treatment with Lutonix™ 035 DCB resulted in a freedom from primary safety event rate of 86.8% versus 81.9% with PTA alone (p=0.185). Primary safety defined as composite of freedom from all-cause perioperative death and freedom at 1 year in the index limb from Amputation (ATK or BTK), Reintervention, and Index-limb related death. Numbers reported are Kaplan-Meier analyses, not pre-specified.
- As of May 2023. 300 mm only available on select 0.018 guidewire sizes.
- GeoAlign™ Markers are not a replacement for fluoroscopy. When the catheter is exposed to the vascular system, the location of the balloon should be confirmed while under high quality fluoroscopic observation. 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, control n = 16). Animal data on file. BD Animal test results may not be indicative of clinical performance. Different test methods may yield different results.
Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information. ℞ only
Formulation
The Lutonix™ DCB formulation was designed for the optimal balance of safety and efficacy with a dose of 2 μg/mm2 and polysorbate and sorbitol excipients, which together allow for an effective transfer of drug to the vessel wall.
Uniform Coating
The Lutonix™ 035 DCB demonstrated a consistent coating resulting in:
- 360° of paclitaxel coating at the target vessel1
- ~6.46 μm coating thickness1
Durable Coating
The Lutonix™ DCB coating formulation is designed to:
- Ensure rapid uptake of the drug to the vessel wall during inflation
- Provide uniform delivery of the drug to the vessel wall
- Help minimize unnecessary drug exposure to staff and patients
In a dry inflate shake test, the Lutonix™ 035 DCB showed a <0.1% drug loss2
Data from a Pre-Clinical Animal Study showed Lutonix™ DCB had desired pharmacologic levels with biologic effects without evidence of significant downstream emboli or systemic toxicity.3
1 Bench test and pre-clinical animal study data on file. Bench test results and preclinical data 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 the device against the sides of a centrifuge tube, left and right, five times. n=5. Bench test results may not be indicative of clinical performance. Different test methods may yield different results.
3 Virmani Pre-Clinical Animal Data GLP Study. Pre-clinical data on file. Pre-clinical results may not be indicative of clinical performance. Different test methods may yield different results.
Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information. ℞ only
BD-38946
The Lutonix Global Registry showed sustained efficacy of Lutonix™ 035 DCB in heterogeneous patient population in real-world clinical practice.1
The primary efficacy endpoint was measured as Kaplan-Meier (KM) freedom full Target Lesion Revascularization and found to be 94.1% at 12 months and 90.3% at 24 months.1
The efficacy of the Lutonix™ 035 DCB was maintained in long lesions and in-stent restenosis subgroups with 88.2% and 84.6% freedom from TLR at 24 months, respectively.1
The LEVANT 2 pivotal study is a global, prospective, single-blind, randomized, 54-site study (42 sites in the United States and 12 in Europe) that enrolled all patients under one protocol, comparing the Lutonix™ 035 DCB with standard PTA.2
The study met its primary endpoints for safety and efficacy.
- Safety: Lutonix™ 035 demonstrated a safety profile that is consistent with PTA
- Efficacy: Lutonix™ 035 demonstrated a 29.4% better primary patency rate at 12 months than PTA
1 Lutonix Global SFA Real-World Registry, n=691. The primary safety endpoint was freedom from target vessel reintervention, major index limb amputation, and device- or procedure related death at 30 days. Freedom from primary safety events at 30 days was 99.4% (681/681). Primary efficacy endpoint is defined as freedom from TLR at 12 months. TLR-Free rate by subject counts at 12 months was 93.4% (605/648). The Kaplan-Meier TLR-Free survival estimate was 94.1% at 12 months and 90.3% at 24 months. All subjects treated with the Lutonix™ 035 DCB. In the LEVANT 2 IDE Clinical Trial, treatment with Lutonix™ 035 DCB resulted in freedom from TLR rate of 87.7% at 12 months (250/285) and a freedom from TLR rate of 82.0% at 24 months. Data on file, Becton, Dickinson and Company.
2 LEVANT 2 clinical trial data on file. N=476. At 12 months, treatment with Lutonix™ 035 resulted in a primary patency rate of 73.5% versus 56.8% with PTA alone (p=0.001). Primary patency defined as absence of binary restenosis defined by DUS PSVR ≥ 2.5 and freedom from Target Lesion Revascularization (TLR). At 12 months, treatment with Lutonix™ 035 DCB resulted in a freedom from primary safety event rate of 86.8% versus 81.9% with PTA alone (p=0.185). Primary safety defined as composite of freedom from all-cause perioperative death and freedom at 1 year in the index limb from Amputation (ATK or BTK), Reintervention, and Index-limb related death. Numbers reported are Kaplan-Meier analyses, not pre-specified.
Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information. ℞ only
BD-38946
Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information. ℞ only
BD-38946
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Please consult Instructions for Use for product indications for use, contraindications, warnings, precautions, complications, adverse events and detailed safety information. ℞ only
BD-38946
Lutonix™ Drug Coated Balloon PTA Catheter
Safety and Risk Information
Lutonix™ 035 DCB
Intended Use/ Indications for Use
The Lutonix™ 035 Drug Coated Balloon Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature and for the treatment of obstructive lesions and decreasing the incidence of restenosis. In addition, the Lutonix™ 035 Drug Coated Balloon Catheter is intended for PTA of native dialysis fistulae or synthetic grafts, opening narrowing and immature fistulae, to improve blood flow, and decreasing the incidence of restenosis.
Contraindications
The Lutonix™ Catheter is contraindicated for use in:
Patients who cannot receive recommended anti-platelet and/or anticoagulant therapy. Women who are breastfeeding, pregnant or are intending to become pregnant or men intending to father children. 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. Pediatric patients. The safety and effectiveness of the Lutonix™ Catheter in pediatric patients has not been established. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system. This product should not be used in patients with known hypersensitivity to paclitaxel or structurally related compounds.
Warnings
1) 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. Physicians should discuss this late mortality signal and the benefits and risks of available treatment options with their patients.
2) Contents supplied STERILE using ethylene oxide (EO) process. Do not use if sterile barrier is damaged or opened prior to intended use.
3) Do not use if product damage is evident.
4) The Lutonix™ DCB Catheter is for use in one patient only; do not reuse in another patient, reprocess or resterilize. Risks of reuse in another patient, reprocessing, or resterilization include: – Compromising the structural integrity of the device and/or device failure which, in turn, may result in patient injury, illness or death. – Creating a risk of device contamination and/or patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to patient injury, illness or death.
5) Do not exceed the Rated Burst Pressure (RBP) recommended for this device. Balloon rupture may occur if the RBP rating is exceeded. To prevent over-pressurization, use of a pressure monitoring device is recommended.
6) Use the recommended balloon inflation medium of contrast and sterile saline (≤50% contrast). Never use air or any gaseous medium to inflate the balloon.
7) This product should not be used in patients with known hypersensitivity to paclitaxel or structurally related compounds.
8) The safety and effectiveness of the Lutonix™ Catheter have not been established for treatment in cerebral, carotid, coronary, or renal vasculature.
9) The safety and effectiveness of using more than four Lutonix™ drug coated balloons or a maximum drug coating quantity of approximately 15.1 mg paclitaxel in a patient has not been clinically evaluated.
Precautions
1) The Lutonix™ DCB Catheter should only be used by physicians trained in percutaneous interventional procedures.
2) Consideration should be given to the risks and benefits of use in patients with a history of non-controllable allergies to contrast agents.
Use in Conjunction with Other Procedures
The safety and effectiveness of the Lutonix™ Catheter used in conjunction with other drug eluting stents or drug coated balloons in the same procedure or following treatment failure has not been evaluated.
Note: Use with bare metal stents for bailout if needed in the same procedure following treatment with the Lutonix™ Catheter is permitted.
Potential Adverse Events
Potential adverse events which may be associated with a peripheral balloon dilatation procedure include: Additional intervention ∙ Allergic reaction to drugs, excipients, or contrast medium ∙ Amputation/loss of limb ∙ Aneurysm or pseudoaneurysm ∙ Arrhythmias ∙ Embolization ∙ Hematoma ∙ Hemorrhage, including bleeding at the puncture site ∙ Hypotension/hypertension ∙ Inflammation ∙ Occlusion ∙ Pain or tenderness ∙ Pneumothorax or hemothorax ∙ Sepsis/infection ∙ Shock ∙ Stroke ∙ Thrombosis ∙ Vessel dissection, perforation, rupture, or spasm ∙ Although systemic effects are not anticipated, refer to the Physicians’ Desk Reference for more information on the potential adverse events observed with paclitaxel. Potential adverse events, not described in the above source, which may be unique to the paclitaxel drug coating include: Allergic/immunologic reaction to the drug coating (paclitaxel) ∙ Alopecia ∙ Anemia ∙ Blood product transfusion ∙ Gastrointestinal symptoms ∙ Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia) ∙ Hepatic enzyme changes ∙ Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis ∙ Myalgia/Arthralgia ∙ Myelosuppression ∙ Peripheral neuropathy
Please consult product labels and instructions for use for indications, contraindications, hazards, warnings and precautions.
BD, the BD logo, and Lutonix are trademarks of Becton, Dickinson and Company or its affiliates. © 2023 BD. All rights reserved.
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