📊 Evidence-Based Reference
Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter Model PTA3
Summary: The Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter by Cook is a device used primarily for venous stent procedures. It is FDA 510(k) cleared with evidence from 10 studies supporting its use.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K122940 ↗
Decision Date ?
March 19, 2013
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter was cleared through the FDA 510(k) pathway on March 19, 2013. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The device is a balloon dilatation catheter designed for use in venous stent procedures. It features an ultra-low profile to facilitate access and navigation through the vascular system.
FDA-Cleared Indications
- Percutaneous transluminal angioplasty of peripheral blood vessels.
- Dilatation of stenotic or obstructed peripheral vessels before or after interventional treatment.
- Use in adults when balloon catheter dilation is clinically indicated and the target vessel is compatible with the device specifications.
Clinical Applications
- Balloon angioplasty of selected peripheral venous stenoses.
- Dilation of a venous segment before venous stent placement.
- Post-dilation of a deployed venous stent when additional expansion is needed.
- Treatment of difficult-to-access peripheral vascular lesions where a low-profile balloon catheter is appropriate.
Reported off-label uses
- Balloon dilation of selected arterial lesions when the device size, pressure limits, and anatomy are appropriate; arterial use must be evaluated against the specific labeling.
- Dilation of dialysis-access stenoses in selected cases, depending on the device's labeled vessel and size specifications.
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.
Evidence Summary
The literature includes 10 studies, primarily focusing on the device's application in venous stenting. These studies span a range of publication years, providing a comprehensive overview of its clinical utility.
Reported Outcomes
Published studies report that the Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter effectively facilitates venous stent placement with high success rates. The device's design allows for improved navigation and access in complex vascular scenarios.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a low incidence of device-related complications. The catheter's design minimizes the risk of vessel trauma during procedures.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of randomized controlled trials. Further research is needed to establish long-term outcomes and comparative effectiveness with other devices.
Practical Considerations
- The catheter is designed for guidewire-based delivery through a small access system; the compatible guidewire, sheath, balloon diameter, and working length must be confirmed in the current instructions for use.
- Use fluoroscopic or other appropriate imaging guidance, with contrast injection as needed to define the vessel and balloon position.
- Do not exceed the labeled rated burst pressure. Inflate and deflate the balloon according to the manufacturer's instructions to reduce the risk of vessel injury or balloon damage.
- Check the current labeling for MRI safety or conditional-use conditions; MRI status should not be assumed from the device name alone.
- Contraindications and precautions include inability to cross the lesion, severe vessel tortuosity, uncorrected bleeding risk, active infection at the access site, and anatomy that is incompatible with the catheter specifications.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Advance Micro 14 Ultra Low Profile Balloon Dilatation Catheter?
The device is indicated for use in venous stent procedures, particularly in cases requiring vessel dilation for stent placement.
What outcomes have been reported in clinical studies?
Studies report high success rates in stent placement with effective vessel dilation and minimal complications.
What complications have been reported?
Safety data indicate a low incidence of complications, primarily related to vessel trauma, which are minimized by the device's design.
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.