đź“Š Evidence-Based Reference
crossover
Thomas Medical Products
Summary: The crossover device by Thomas Medical Products is used in embolization procedures. It is FDA 510k cleared and supported by 15 studies, focusing on its application in embolization-coils.
FDA Clearance Information
Pathway
510K
Number
K083269 ↗
Decision Date
February 3, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The crossover device received FDA clearance through the 510k pathway on February 3, 2009. It is manufactured by Thomas Medical Products and is classified as a Class 2 device.
What It Is
The crossover is a medical device designed for use in embolization procedures, specifically involving embolization-coils. It functions by facilitating the delivery and placement of coils to occlude blood vessels, aiding in the treatment of vascular abnormalities.
Clinical Applications
The crossover device is commonly used in interventional radiology for the treatment of aneurysms and other vascular malformations. It is particularly useful in scenarios requiring precise coil placement to achieve vessel occlusion.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and case series. These studies span from 2023 to 2024, providing insights into the device's clinical applications and outcomes.
Reported Outcomes
Published studies report that the crossover device effectively facilitates embolization with high precision in coil placement. The studies highlight its role in achieving successful vessel occlusion in a majority of cases, contributing to positive clinical outcomes in embolization procedures.
Safety Profile
Reported complications include device-related malfunctions and procedural difficulties, although these are infrequent. The studies emphasize the importance of operator experience in minimizing adverse events.
Evidence Limitations
The current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to establish the device's efficacy across diverse patient populations and to explore potential improvements in design.
Frequently Asked Questions
What are the clinical indications for crossover?
The crossover device is indicated for use in embolization procedures, particularly involving embolization-coils for the treatment of vascular abnormalities.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful vessel occlusion and high precision in coil placement, leading to positive outcomes in embolization procedures.
What complications have been reported?
Safety data indicate that complications are rare but can include device-related malfunctions and procedural difficulties, often mitigated by experienced operators.
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.