📋 FDA Reference
AngioDynamics Profiler PTA Balloon Catheter
Summary: The Angiodynamics Profiler PTA Balloon Catheter is a medical device used to dilate narrowed blood vessels, commonly employed by interventional radiologists and vascular surgeons. It is primarily used in procedures involving venous stents.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K051060 ↗
Decision Date ?
May 26, 2005
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Angiodynamics Profiler PTA Balloon Catheter was cleared through the FDA 510(k) pathway on May 26, 2005. Manufactured by Angiodynamics, it is classified as a Class 2 device under product code DQY.
What It Is
The Angiodynamics Profiler PTA Balloon Catheter is a percutaneous transluminal angioplasty (PTA) device designed to dilate stenotic segments of blood vessels. It consists of a balloon at the tip of a catheter, which is inflated to open up narrowed areas in the vasculature. This device is crucial in restoring adequate blood flow and is often used in conjunction with stenting procedures.
FDA-Cleared Indications
- Dilation of stenotic lesions in peripheral vasculature, including the venous system, using percutaneous transluminal angioplasty.
- Use in conjunction with standard interventional techniques and compatible guidewires to restore or improve vessel lumen diameter.
Clinical Applications
- Percutaneous dilation of narrowed peripheral veins.
- Balloon angioplasty of venous stenosis before or during venous stent placement.
- Post-deployment expansion or optimization of a compatible venous stent when clinically indicated.
- Treatment of vessel narrowing in catheter-based vascular procedures performed in an interventional radiology or vascular surgery setting.
Reported off-label uses
- Balloon angioplasty of selected peripheral arterial stenoses when the specific catheter size, balloon rating, and labeling support the planned procedure; this should not be assumed from the venous indications.
- Adjunctive dilation of access-related or post-thrombotic venous stenosis outside the device's specifically described labeled application.
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
- Choose the balloon diameter and length to match the target vessel and lesion; oversizing can increase the risk of dissection, rupture, or other vessel injury.
- The catheter is advanced over a compatible guidewire under fluoroscopic imaging. Confirm position before inflation and follow the device's rated pressure limits.
- Available sizes and shaft or guidewire compatibility depend on the specific catalog configuration and should be verified in the current manufacturer instructions for use.
- MRI safety depends on the exact device configuration and whether the catheter remains in or has been removed from the patient. Check the current labeling before MRI; do not assume that an indwelling catheter is MRI safe.
- Potential complications include vessel dissection, perforation or rupture, bleeding, thrombosis, embolization, infection, contrast reaction, and restenosis. Contraindications and warnings in the current instructions for use should be reviewed before treatment.
Procedures that use this device
Frequently Asked Questions
What is the Angiodynamics Profiler PTA Balloon Catheter used for?
It is used to dilate narrowed blood vessels, particularly in the venous system, to restore adequate blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for dilating narrowed blood vessels, especially in the venous system, to treat conditions like peripheral artery disease.
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.