Lutonix 035 Model 9004 and Model 9010

FDA-Cleared Indications

• Reduce the frequency of residual-solvent testing from testing every individual lot to testing a single lot per month.

Clinical Applications

• Use as a drug-eluting peripheral transluminal angioplasty catheter within the device's labeled quality and manufacturing framework.
• Use in peripheral angioplasty procedures only when the clinical application is consistent with the current device labeling and instructions for use.

Reported off-label uses

• Treatment of stenosis in hemodialysis arteriovenous fistulae.
• Treatment of stenosis in other peripheral arteries.
• Treatment of recurrent peripheral vascular stenosis after prior angioplasty.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The supplied FDA indication is a residual-solvent testing requirement, not a patient-treatment indication. Clinicians should confirm the current FDA labeling and instructions for use before clinical use.
• The available record does not provide balloon diameters, lengths, guidewire requirements, sheath compatibility, inflation pressures, or lesion-length limits; consult the current product labeling for these specifications.
• Use requires fluoroscopic or other appropriate imaging guidance, vascular access, and standard angioplasty technique.
• Paclitaxel-coated balloons require attention to preparation, lesion crossing, inflation time, and handling according to the manufacturer’s instructions.
• MRI safety information is not provided in the supplied FDA record. Check the device labeling for MR Safe, MR Conditional, or other MRI guidance before scanning.