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agiltrac 035 peripheral dilatation catheter
Guidant
Summary: The Agiltrac 035 is a peripheral dilatation catheter designed for venous stent procedures. It is primarily used to dilate peripheral vessels. Key evidence includes studies on its safety and efficacy in various vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K023320 ↗
Decision Date
December 10, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Agiltrac 035 Peripheral Dilatation Catheter was cleared by the FDA via the 510(k) pathway on December 10, 2002. It is manufactured by Guidant and classified as a Class 2 medical device.
What It Is
The Agiltrac 035 is a balloon catheter used for dilating peripheral vessels, particularly in venous stent procedures. It is designed to facilitate the expansion of narrowed or obstructed blood vessels to improve blood flow.
Clinical Applications
This device is commonly used in procedures involving the dilation of peripheral arteries and veins, particularly in cases requiring venous stenting. It is utilized in clinical settings where vessel expansion is necessary to restore adequate blood circulation.
Evidence Summary
The available literature includes 8 studies, encompassing various study types such as RCTs and case series, conducted between 2020 and 2023. These studies evaluate the safety and efficacy of the device in different vascular interventions.
Reported Outcomes
Published studies report that the Agiltrac 035 catheter is effective in dilating peripheral vessels, with successful outcomes in restoring vessel patency. The device has been shown to maintain blood flow in treated vessels, contributing to improved clinical outcomes in vascular interventions.
Safety Profile
Reported complications include early elastic recoil after balloon dilatation and potential vascular complications associated with multiple arterial access. However, the overall safety profile is considered acceptable for its intended use.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up data in some studies. Further research is needed to establish comprehensive safety and efficacy profiles, particularly in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Agiltrac 035 Peripheral Dilatation Catheter?
The Agiltrac 035 is indicated for use in dilating peripheral vessels, particularly in venous stent procedures and other vascular interventions requiring vessel expansion.
What outcomes have been reported in clinical studies?
Studies have reported successful vessel dilation and maintained blood flow, contributing to improved clinical outcomes in vascular interventions.
What complications have been reported?
Reported complications include early elastic recoil and potential vascular complications from multiple arterial access, though the safety profile is generally acceptable.
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.