Armada 14 NC PTA Catheter
Abbott Medical
FDA Clearance Information
FDA-Cleared Indications
- Percutaneous transluminal angioplasty of stenotic lesions in peripheral arteries.
- Treatment of stenotic lesions in arteriovenous dialysis fistulas and grafts.
- The catheter is intended for use with compatible guidewires and angioplasty equipment in appropriately selected patients.
Clinical Applications
- Balloon angioplasty of peripheral arterial stenosis.
- Treatment of narrowing in hemodialysis arteriovenous fistulas.
- Treatment of narrowing in hemodialysis arteriovenous grafts.
- Post-treatment dilation of selected peripheral vascular lesions when appropriate for the catheter specifications.
Reported off-label uses
- Treatment of selected venous stenoses outside dialysis access, such as iliac or central venous narrowing, when judged appropriate by the treating specialist.
- Balloon preparation or post-dilation during selected peripheral vascular interventions.
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 Armada 14 NC is a noncompliant balloon catheter; the available balloon diameters, lengths, shaft configuration and rated pressure must match the target vessel and lesion.
- Use requires compatible guidewire, introducer sheath and other equipment. The catheter is advanced under fluoroscopic imaging, commonly through femoral or another suitable vascular access site.
- Contraindications and warnings include inability to safely cross the lesion, significant vessel dissection or perforation risk, uncorrected bleeding disorders, and known severe hypersensitivity to catheter materials or required contrast agents.
- MRI safety depends on the exact catheter model and whether it remains in the body. A temporary angioplasty catheter is generally removed after treatment; confirm the current manufacturer MRI labeling before scanning.
- Potential complications include vessel dissection, perforation, thrombosis, embolization, bleeding, access-site complications, restenosis and contrast-related adverse events.
Procedures that use this device
Frequently Asked Questions
What is the Armada 14 NC PTA Catheter used for?
It is a noncompliant balloon catheter used to widen narrowed peripheral blood vessels and stenosed hemodialysis fistulas or grafts during angioplasty.
Is the Armada 14 NC PTA Catheter MRI safe?
The catheter is normally removed after angioplasty, so it is not a permanent implant. Confirm the exact model's current manufacturer MRI information before an MRI examination.
What sizes does the Armada 14 NC PTA Catheter come in?
Available balloon diameters and lengths depend on the specific catalog number and product configuration. The treating clinician selects a size based on the vessel diameter, lesion length and required pressure.
How long does the Armada 14 NC PTA Catheter last?
It is a single-use procedure catheter and is not intended to remain in the body or provide permanent treatment. Vessel patency after angioplasty varies with the disease, treated vessel and patient factors.
How much does the Armada 14 NC PTA Catheter cost?
The device price is usually not listed separately for patients. Total cost depends on the facility, procedure, imaging, anesthesia or sedation, physician fees and insurance coverage.