📋 FDA Reference
lutonix 035 model 9004 and model 9010
Lutonix
Summary: The Lutonix 035 models 9004 and 9010 are drug-coated balloons used to treat stenosis in AV fistulae. They are primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway PMA
Number P130024 ↗
Decision Date September 4, 2025
Product Code ONU
Device Class Class 3
Evidence 4 studies
The Lutonix 035 models 9004 and 9010 received FDA clearance under PMA P130024 on September 4, 2025. Manufactured by Lutonix, this Class 3 device is indicated for reducing the frequency of residual solvent testing.
What It Is
The Lutonix 035 is a drug-coated balloon catheter designed to deliver paclitaxel to the vessel wall, inhibiting restenosis. It is used in angioplasty procedures, particularly for patients with arteriovenous (AV) fistulae. The device's drug coating helps maintain vessel patency by preventing tissue regrowth that can lead to narrowing.
Clinical Applications
This device is commonly used in the management of stenosis in AV fistulae, which are critical for patients undergoing hemodialysis. Interventional radiologists and vascular surgeons utilize these balloons in outpatient settings or hospital catheterization labs to improve blood flow and prolong the usability of the fistula. It is particularly beneficial for patients with chronic kidney disease requiring dialysis access maintenance.
Indications for Use
The FDA indication allows for reduced frequency of residual solvent testing, meaning quality assurance processes are streamlined. Clinically, the device is used to prevent restenosis in AV fistulae, a common complication in dialysis patients.
Practical Considerations
The Lutonix 035 is available in various sizes to accommodate different vessel diameters. It is compatible with standard angioplasty techniques and equipment. Clinicians should be aware of the specific handling and inflation protocols to maximize drug delivery efficacy.
Related Literature
The Lutonix® Global AV Registry investigated the use of the Lutonix Drug Coated Balloon in treating native and synthetic AV fistulae. While the study's abstract is unavailable, it likely focused on the device's efficacy in maintaining fistula patency. Limitations may include a lack of long-term outcome data and variability in patient populations.
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 is Lutonix 035 used for?
It is used to treat stenosis in arteriovenous fistulae, commonly in patients undergoing dialysis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is cleared for reducing the frequency of residual solvent testing and is used to prevent restenosis in AV fistulae.
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.