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edwards directional catheter
Edwards Lifesciences
Summary: The Edwards Directional Catheter is a medical device used primarily for venous interventions. It is FDA 510k cleared and supported by 10 studies, focusing on its application in venous-stents.
FDA Clearance Information
Pathway
510K
Number
K030630 ↗
Decision Date
September 3, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Edwards Directional Catheter was cleared via the FDA 510k pathway on September 3, 2003. It is manufactured by Edwards Lifesciences and classified as a Class 2 device.
What It Is
The Edwards Directional Catheter is designed for use in venous interventions, particularly in the placement and management of venous stents. It facilitates targeted delivery and positioning within the venous system.
Clinical Applications
Commonly used in procedures involving venous stenting, the Edwards Directional Catheter is employed in cases of venous thrombosis and other vascular conditions requiring precise catheter placement.
Evidence Summary
The literature includes 10 studies, encompassing randomized controlled trials and observational studies, published between 2023 and 2025. These studies explore the catheter's efficacy and safety in venous interventions.
Reported Outcomes
Published studies report that the Edwards Directional Catheter is effective in facilitating venous stenting procedures. It has shown utility in reducing procedural time and improving stent placement accuracy in venous interventions.
Safety Profile
Reported complications include minor procedural bleeding and catheter-related thrombosis. Overall, the safety profile is consistent with other devices in its class, with no significant adverse events reported in the reviewed studies.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials directly comparing the Edwards Directional Catheter to alternative devices. Further research is needed to establish long-term outcomes and comparative efficacy.
Frequently Asked Questions
What are the clinical indications for Edwards Directional Catheter?
The Edwards Directional Catheter is indicated for use in venous stenting procedures, particularly in cases of venous thrombosis and other vascular conditions requiring precise catheter placement.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural efficiency and stent placement accuracy when using the Edwards Directional Catheter in venous interventions.
What complications have been reported?
Safety data from evidence indicate minor procedural bleeding and catheter-related thrombosis as reported complications, with no significant adverse events noted.
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.