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irrigation catheter 4 6 and 10 french
Applied Vascular Devices
Summary: The irrigation catheter by Applied Vascular Devices is used for venous stent procedures. It was FDA cleared via the 510(k) pathway in 1991. Key evidence highlights its efficacy in creating deeper lesions compared to non-irrigated catheters.
FDA Clearance Information
Pathway
510K
Number
K902256 ↗
Decision Date
February 15, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The irrigation catheter by Applied Vascular Devices was cleared by the FDA through the 510(k) pathway on February 15, 1991. It is classified as a Class 2 device under product code DQY.
What It Is
The irrigation catheter is a medical device designed for use in venous stent procedures. It facilitates the delivery of fluids to the target area, enhancing the efficacy of the procedure by maintaining patency and reducing the risk of thrombus formation.
Clinical Applications
This device is commonly used in procedures involving venous stents, particularly where maintaining vessel patency and reducing thrombus risk are critical. It is suitable for use in various clinical settings, including interventional radiology and vascular surgery.
Evidence Summary
The literature includes 15 peer-reviewed studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2023 to 2024, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the irrigation catheter is effective in creating deeper lesions compared to non-irrigated catheters. It has shown reproducible outcomes in the treatment of atrial fibrillation and atrioventricular nodal reentrant tachycardia. The device's efficacy in maintaining vessel patency during venous stent procedures is well-documented.
Safety Profile
Reported complications include periprocedural conduction system damage during atrioventricular nodal reentrant tachycardia ablation. However, the incidence of permanent atrioventricular block is low. Overall, the device is considered safe with a favorable risk-benefit profile.
Evidence Limitations
The evidence base is limited by the lack of long-term follow-up data and the small sample sizes in some studies. Further research is needed to evaluate the device's performance in diverse patient populations and to assess long-term safety and efficacy outcomes.
Frequently Asked Questions
What are the clinical indications for the irrigation catheter?
The irrigation catheter is indicated for use in venous stent procedures to maintain vessel patency and reduce thrombus risk.
What outcomes have been reported in clinical studies?
Studies report effective lesion creation and maintenance of vessel patency, with reproducible outcomes in atrial fibrillation and atrioventricular nodal reentrant tachycardia treatments.
What complications have been reported?
Reported complications include periprocedural conduction system damage, with a low incidence of permanent atrioventricular block.
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.