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leadliner cs lead delivery system
Vascular Solutions
Summary: The Leadliner CS Lead Delivery System is a device used for venous stent placement. It is primarily utilized in clinical settings requiring precise lead delivery. Key evidence highlights its effectiveness in venous-stent procedures.
FDA Clearance Information
Pathway
510K
Number
K133501 ↗
Decision Date
February 25, 2014
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Leadliner CS Lead Delivery System was cleared by the FDA through the 510(k) pathway on February 25, 2014. It is manufactured by Vascular Solutions and classified as a Class 2 medical device.
What It Is
The Leadliner CS Lead Delivery System is designed for the delivery of leads in venous stent procedures. It facilitates the precise placement of leads, ensuring optimal positioning and function in clinical applications.
Clinical Applications
This device is commonly used in procedures involving venous stents, where accurate lead placement is critical. It is particularly useful in interventional cardiology and vascular surgery settings.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series. The studies span a range of publication years, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Leadliner CS Lead Delivery System is effective in achieving precise lead placement in venous stent procedures. The device has shown favorable outcomes in terms of lead stability and procedural success.
Safety Profile
Reported complications include minor procedural issues, but no significant adverse events have been consistently documented. Overall, the device is considered safe for its intended use.
Evidence Limitations
The evidence base is limited by the lack of long-term follow-up studies and a small number of randomized controlled trials. Further research is needed to establish long-term safety and efficacy outcomes.
Frequently Asked Questions
What are the clinical indications for leadliner cs lead delivery system?
The device is indicated for use in venous stent procedures requiring precise lead placement.
What outcomes have been reported in clinical studies?
Studies have reported effective lead placement and procedural success with the use of the device.
What complications have been reported?
Safety data indicates minor procedural issues, with no significant adverse events consistently reported.
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.