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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
510K
Number
K020161 ↗
Decision Date
February 22, 2002
Product Code
DQY
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.
Clinical Applications
This catheter is commonly used in procedures involving peripheral vascular interventions, such as treating stenotic or occluded vessels. It is particularly useful in venous-stent placements and other related vascular 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.
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.