đź“Š Evidence-Based Reference
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Lepu Medical Technology (Beijing)
Summary: The device is a set of embolization coils used for vascular embolization procedures. It is primarily used to occlude blood vessels to prevent blood flow to certain areas. Key evidence includes 15 studies examining its efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K172331 ↗
Decision Date
March 2, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The embolization coils by Lepu Medical Technology were cleared via the FDA 510(k) pathway on March 2, 2018. They are classified as Class 2 medical devices under product code DYB.
What It Is
The device consists of embolization coils designed to occlude blood vessels. It is used in interventional radiology to treat conditions such as aneurysms or to prevent blood flow to tumors. The coils are deployed via catheter and expand to fill the vessel lumen.
Clinical Applications
Commonly used in procedures requiring vascular occlusion, such as treating cerebral aneurysms or controlling bleeding in trauma cases. The coils provide a minimally invasive option for managing vascular conditions.
Evidence Summary
The literature includes 15 studies, encompassing various study types such as RCTs and case series, published between 2022 and 2024. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the embolization coils effectively occlude targeted blood vessels, achieving high rates of procedural success. Outcomes include reduced blood flow to the treated area and resolution of aneurysms in a significant number of cases. The device demonstrates consistent performance across different patient populations.
Safety Profile
Reported complications include minor procedural risks such as local site reactions and transient pain. No major adverse events were consistently reported across studies, indicating a favorable safety profile.
Evidence Limitations
The evidence is limited by the small sample sizes in some studies and the lack of long-term follow-up data. Further research is needed to assess the device's performance in diverse patient populations and over extended periods.
Frequently Asked Questions
What are the clinical indications for embolization coils?
The coils are indicated for vascular embolization procedures, such as treating aneurysms or controlling bleeding.
What outcomes have been reported in clinical studies?
Studies report high procedural success rates with effective vessel occlusion and resolution of aneurysms.
What complications have been reported?
Safety data indicate minor complications such as local site reactions and transient pain, with no major 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.