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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 ?
510(k)
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.
FDA-Cleared Indications
- Use in embolization procedures involving embolization coils.
- Facilitation of coil delivery and placement to occlude blood vessels.
Clinical Applications
- Delivery and placement of embolization coils during endovascular vessel occlusion.
- Coil embolization of aneurysms when treatment requires controlled placement of coils.
- Coil embolization of selected vascular malformations.
- Treatment of other vascular abnormalities requiring coil-based embolization.
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.
Practical Considerations
- The specific device dimensions, working length, catheter compatibility and coil compatibility should be confirmed in the current manufacturer’s instructions for use.
- Use is performed under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- The device is intended to support coil embolization; the embolization coil itself is the material that produces vessel occlusion.
- MRI safety depends on the exact device configuration and labeling. Confirm MR Safe, MR Conditional or MR Unsafe status before MRI; do not assume safety from the 510(k) clearance alone.
- Potential concerns include vascular injury, bleeding, thrombosis, non-target embolization, infection and incomplete or unintended vessel occlusion. Contraindications and precautions are determined by the current labeling and the patient's anatomy and clinical condition.
Procedures that use this device
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.