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radius snare
Radius Medical Technologies
Summary: The radius snare is a medical device used primarily in venous stent procedures. It was cleared by the FDA via the 510k pathway. Key evidence includes studies on its efficacy and safety in clinical settings.
FDA Clearance Information
Pathway
510K
Number
K070502 ↗
Decision Date
October 4, 2007
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The radius snare was cleared by the FDA through the 510k pathway on October 4, 2007. It is manufactured by Radius Medical Technologies and classified as a Class 2 device.
What It Is
The radius snare is a medical device designed for use in venous stent procedures. It functions by facilitating the placement and retrieval of stents within the venous system, aiding in the management of venous obstructions.
Clinical Applications
The radius snare is commonly used in clinical scenarios involving venous stent placements, particularly in cases of venous obstructions where precise stent deployment is critical. It is utilized in interventional radiology and vascular surgery settings.
Evidence Summary
The available literature includes five studies, with a mix of study types such as RCTs and case series. The studies span from 1998 to 2024, providing insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report varying outcomes related to the efficacy of the radius snare in venous stent procedures. While some studies highlight its effectiveness in precise stent placement, others focus on its role in reducing procedural complications. However, specific quantitative outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include potential device-related adverse events, although specific details are not provided in the evidence. The studies suggest a generally favorable safety profile, but further detailed safety data is lacking.
Evidence Limitations
The evidence base for the radius snare is limited by the lack of detailed quantitative outcomes and comprehensive safety data. Further research is needed to fully understand the long-term efficacy and safety of the device in diverse clinical populations.
Frequently Asked Questions
What are the clinical indications for radius snare?
The radius snare is indicated for use in venous stent procedures, particularly in managing venous obstructions.
What outcomes have been reported in clinical studies?
Studies report the radius snare's effectiveness in precise stent placement and its role in reducing procedural complications, though specific outcomes are not detailed.
What complications have been reported?
Reported complications include potential device-related adverse events, but specific safety data is not detailed in the provided evidence.
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.