📊 Evidence-Based Reference
Agiltrac 018 Peripheral Dilatation Catheter
Guidant
Summary: The agiltrac 018 peripheral dilatation catheter by Guidant is a device used for peripheral vascular interventions. It is primarily used in venous-stent procedures. Key evidence includes studies on technical success and lesion crossing success.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K020161 ↗
Decision Date ?
February 22, 2002
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The agiltrac 018 peripheral dilatation catheter was cleared by the FDA via the 510(k) pathway on February 22, 2002. It is manufactured by Guidant and classified as a Class 2 device.
What It Is
The agiltrac 018 peripheral dilatation catheter is designed for dilating peripheral vessels. It is used in clinical settings to facilitate the placement of venous stents, particularly in cases requiring vascular access.
FDA-Cleared Indications
- Percutaneous transluminal dilatation of stenotic peripheral vessels.
- Use in peripheral vascular interventions where balloon dilatation is clinically indicated.
Clinical Applications
- Balloon dilatation of narrowed peripheral arteries or veins.
- Percutaneous treatment of peripheral vascular stenosis.
- Vessel preparation or post-dilatation during selected peripheral endovascular procedures.
Evidence Summary
The literature includes 6 studies, encompassing randomized controlled trials and retrospective analyses, with publication dates ranging from 2007 to 2025. These studies evaluate various aspects of peripheral vascular interventions.
Reported Outcomes
Published studies report a technical success rate of 83.3% in certain procedures and a lesion crossing success rate of 93.2%. Postdilatation residual stenosis was achieved in most patients, indicating effective vessel dilation.
Safety Profile
Reported complications include typical risks associated with vascular interventions, such as vessel injury or restenosis. However, specific adverse events were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of detailed safety data and long-term outcomes. Further research is needed to assess the device's performance in diverse patient populations and clinical scenarios.
Practical Considerations
- The 018 designation refers to a small catheter or guidewire platform; exact balloon diameters, lengths, shaft lengths, and compatibility must be confirmed in the device labeling.
- The catheter is used with fluoroscopic or other appropriate imaging guidance and requires vascular access.
- Contraindications and precautions include inability to safely cross the lesion, significant vascular injury risk, uncorrected bleeding disorders, or allergy to procedural materials such as contrast media when applicable.
- MRI safety depends on the exact catheter model and whether any component remains in the patient; review the current labeling before MRI.
- As a temporary catheter, it is not intended for permanent implantation and does not have a defined long-term indwelling lifespan.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for agiltrac 018 peripheral dilatation catheter?
The catheter is indicated for use in peripheral vascular interventions, particularly for dilating vessels prior to venous-stent placement.
What outcomes have been reported in clinical studies?
Studies have reported a technical success rate of 83.3% and a lesion crossing success rate of 93.2%, with effective postdilatation outcomes.
What complications have been reported?
Reported complications include general risks of vascular procedures, but specific adverse events were not detailed in the provided studies.
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.