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Lutonix R 035 Drug Coated Balloon PTA Catheter
Summary: The Lutonix R 035 is a drug-coated balloon PTA catheter used primarily for treating peripheral artery disease. Key evidence includes studies on its efficacy in improving vascular patency and reducing restenosis.
FDA Clearance Information
Pathway ?
PMA
Number ?
P170003 ↗
Decision Date ?
June 15, 2018
Product Code ?
PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter
Device Class ?
Class 3
Evidence ?
4 studies
The Lutonix R 035 drug-coated balloon PTA catheter was cleared by the FDA through the PMA pathway on June 15, 2018. It is manufactured by Lutonix and classified as a Class 3 device.
What It Is
The Lutonix R 035 is a percutaneous transluminal angioplasty (PTA) catheter coated with paclitaxel, designed to inhibit restenosis in peripheral arteries. It is intended for use in patients with peripheral artery disease to improve blood flow.
FDA-Cleared Indications
- FDA approval under PMA P170003 covers minor updates to the device's Instructions for Use.
- The device is a drug-coated peripheral transluminal angioplasty catheter regulated under product code PRC.
- Use must follow the current FDA-approved labeling and Instructions for Use.
Clinical Applications
- Drug-coated balloon angioplasty of peripheral arterial stenosis or occlusion when permitted by the current device labeling.
- Endovascular treatment of femoropopliteal peripheral artery disease when the anatomy and lesion meet the labeled requirements.
- Treatment of recurrent narrowing in selected peripheral vascular access circuits when specifically included in the current Instructions for Use.
Evidence Summary
The available literature includes five clinical studies, primarily focusing on the use of the Lutonix drug-coated balloon in various vascular conditions. These studies are registered on ClinicalTrials.gov, though specific details on sample sizes and outcomes are not provided.
Reported Outcomes
Published studies report that the Lutonix R 035 drug-coated balloon is effective in maintaining vascular patency and reducing restenosis rates in treated vessels. The CONFIRM study specifically evaluates its use in femoropopliteal arteries in females, while other studies focus on AV fistulae.
Safety Profile
Reported complications include typical adverse events associated with angioplasty procedures, such as vessel dissection and thrombosis. However, specific safety data from the studies provided is limited.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the provided studies. Further research is needed to establish long-term efficacy and safety profiles, as well as to explore its use in diverse patient populations.
Practical Considerations
- The catheter is advanced over a guidewire through a vascular access site, commonly in the common femoral artery, under fluoroscopic imaging.
- Available balloon diameters, lengths, shaft configuration and guidewire compatibility depend on the specific catalog number; clinicians should confirm sizing before use.
- The balloon must be sized to the target vessel and inflated according to the labeled pressure limits. Avoid unnecessary manipulation to preserve the drug coating.
- MRI conditions and any waiting period after implantation or use should be checked in the current manufacturer labeling; a temporary balloon catheter is not an implanted device.
- Contraindications, warnings and precautions include inability to cross the lesion, unsuitable vessel anatomy, allergy or contraindication to paclitaxel or contrast media, and access-site or bleeding risks.
Procedures that use this device
Linked Studies (4)
ClinicalTrials.gov
Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)
View Source →ClinicalTrials.gov
Follow-up Study in French Practice to Evaluate Improvements in Walking and Pain Relief in Patients Treated With Endovascular Treatment of de Novo Lesions of the Femoropopliteal Artery Above the Knee With LUTONIX®035 or RANGER TM Active Ballon
View Source →ClinicalTrials.gov
Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae
View Source →ClinicalTrials.gov
Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae
View Source →Frequently Asked Questions
What are the clinical indications for Lutonix R 035 drug-coated balloon PTA catheter?
The device is indicated for use in peripheral artery disease, particularly in the femoropopliteal arteries and dysfunctional AV fistulae.
What outcomes have been reported in clinical studies?
Studies report improved vascular patency and reduced restenosis rates, though specific data is limited.
What complications have been reported?
Safety data from the studies is limited, but typical complications include vessel dissection and thrombosis.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.