📊 Evidence-Based Reference
Aviator Peripheral Dilatation Catheter
Guidant
Summary: The Aviator Peripheral Dilatation Catheter is a medical device used primarily for dilating peripheral arteries. It is FDA 510k cleared and linked to studies focusing on arterial disease treatment. Key evidence highlights its application in venous-stents.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K010831 ↗
Decision Date ?
June 13, 2001
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Aviator Peripheral Dilatation Catheter, manufactured by Guidant, received FDA clearance through the 510k pathway on June 13, 2001. It is classified as a Class 2 device under product code DQY.
What It Is
The Aviator Peripheral Dilatation Catheter is designed to facilitate the dilation of peripheral arteries. It is used in clinical settings to improve blood flow in patients with arterial blockages, particularly in the context of venous-stents.
FDA-Cleared Indications
- Percutaneous transluminal dilatation of peripheral blood vessels.
- Use in the peripheral vasculature to treat vessel narrowing and improve blood flow.
- Use as an adjunct during peripheral vascular interventions, including procedures involving stent placement when indicated by the treating physician.
Clinical Applications
- Balloon dilatation of narrowed peripheral arteries.
- Percutaneous treatment of peripheral arterial stenosis.
- Predilatation or postdilatation during selected peripheral stent procedures.
- Endovascular treatment of peripheral vascular disease when balloon angioplasty is clinically appropriate.
Reported off-label uses
- Balloon dilatation of selected venous stenoses or venous stents may be reported in clinical practice, but this should not be assumed to be an FDA-cleared indication for this specific device.
- Use in other vascular territories or procedural techniques outside the device labeling may occur under physician judgment and institutional protocols.
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 available literature includes five studies, primarily focusing on peripheral arterial disease and related interventions. These studies are registered on clinical trial platforms, though specific details on sample sizes and outcomes are not provided.
Reported Outcomes
Published studies report on the effectiveness of the Aviator Peripheral Dilatation Catheter in enhancing arterial patency and supporting stent placement. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include procedural risks typical of catheter-based interventions, though specific adverse events are not detailed in the provided studies. Further research is needed to fully characterize the safety profile.
Evidence Limitations
The evidence base is limited by a lack of detailed outcome data and specific safety findings. Further research is necessary to establish comprehensive efficacy and safety profiles, as well as to explore long-term outcomes.
Practical Considerations
- The available catheter diameters, balloon lengths, shaft lengths, guidewire requirements, and maximum inflation pressures depend on the specific model and size; consult the device labeling before use.
- Confirm compatibility with the introducer sheath, guidewire, contrast medium, and any stent or other equipment used in the procedure.
- The catheter is intended for use with fluoroscopic or other appropriate imaging guidance and should be advanced and inflated carefully to reduce the risk of vessel injury, dissection, perforation, thrombosis, or embolization.
- MRI safety cannot be determined from the FDA 510(k) summary alone. Check the exact product labeling and current manufacturer information before MRI exposure.
- Contraindications and warnings may include inability to cross the lesion, severe vessel tortuosity or calcification, uncorrected bleeding risk, contrast allergy, and vessel anatomy unsuitable for balloon angioplasty.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for aviator peripheral dilatation catheter?
The device is indicated for use in procedures requiring the dilation of peripheral arteries, particularly in the context of venous-stents.
What outcomes have been reported in clinical studies?
Studies report on the catheter's role in improving arterial patency and supporting stent placement, though specific outcomes are not detailed.
What complications have been reported?
Reported complications include general procedural risks, but specific adverse events are not detailed in the provided evidence.
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.