đź“Š Evidence-Based Reference
modification to outback catheter
Lumend
Summary: The modification to the Outback Catheter by Lumend is a device used primarily for venous stenting. It has been FDA cleared via the 510k pathway. Two studies provide evidence on its use in peripheral arteries above and below the knee.
FDA Clearance Information
Pathway
510K
Number
K040771 ↗
Decision Date
April 23, 2004
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The modification to the Outback Catheter was cleared by the FDA through the 510k pathway on April 23, 2004. It is manufactured by Lumend and classified as a Class 2 device.
What It Is
The modification to the Outback Catheter is designed to assist in the placement of venous stents. It is used in interventional procedures to improve blood flow in peripheral arteries, particularly in challenging anatomical scenarios.
Clinical Applications
This device is commonly used in clinical settings for patients requiring venous stenting, especially in peripheral arteries. It is particularly useful in cases where traditional catheterization techniques are insufficient.
Evidence Summary
The available literature includes two studies focusing on the use of the device in peripheral arteries above and below the knee. These studies are registered on ClinicalTrials.gov, but detailed outcomes and safety data are not provided.
Reported Outcomes
Published studies report the use of the modification to the Outback Catheter in peripheral artery procedures, but specific efficacy findings are not detailed in the available evidence.
Safety Profile
Reported complications include general risks associated with catheterization and stenting procedures, but specific safety data from the studies are not provided.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the available studies. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for modification to outback catheter?
The device is indicated for use in venous stenting, particularly in peripheral arteries.
What outcomes have been reported in clinical studies?
Specific outcomes are not detailed in the available studies.
What complications have been reported?
General catheterization and stenting risks are noted, but specific complications are not detailed in the 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.