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Boomerang Closurewire Vascular Closure System
Summary: The Boomerang ClosureWire Vascular Closure System by Cardiva Medical is a device for vascular closure post-procedures. Key evidence highlights its use as an adjunct to manual compression, with studies exploring its safety and efficacy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K051817 ↗
Decision Date ?
December 6, 2006
Product Code ?
DXC Clamp, Vascular
Device Class ?
Class 2
Evidence ?
0 studies
The Boomerang ClosureWire Vascular Closure System was cleared via the FDA 510(k) pathway on December 6, 2006. Manufactured by Cardiva Medical, it is classified as a Class 2 device.
What It Is
The Boomerang ClosureWire Vascular Closure System is designed to assist in the closure of vascular access sites following diagnostic or interventional procedures. It functions as an adjunct to manual compression, facilitating hemostasis.
FDA-Cleared Indications
- Aid in achieving hemostasis at vascular access sites after diagnostic or interventional procedures.
- Use as an adjunct to manual compression for closure of vascular puncture sites.
Clinical Applications
- Closure of femoral arterial access sites after angiography.
- Assistance with hemostasis after interventional vascular procedures.
- Adjunctive management of vascular access sites when manual compression is used.
- Post-procedure access-site management when earlier mobilization is clinically appropriate.
Evidence Summary
The available literature includes randomized controlled trials and systematic reviews, with studies published between 2009 and 2017. These studies evaluate the device's efficacy and safety compared to manual compression.
Reported Outcomes
Published studies report that the Boomerang ClosureWire can reduce time to hemostasis and facilitate earlier patient mobilization compared to manual compression alone. It does not compromise arterial integrity, allowing for future interventions.
Safety Profile
Reported complications include access site complications, which are significant in diagnostic and therapeutic interventions. However, the device does not alter arterial integrity, suggesting a favorable safety profile.
Evidence Limitations
The evidence is limited by the small number of studies directly comparing the Boomerang ClosureWire to other vascular closure devices. Further research is needed to establish long-term outcomes and broader clinical applicability.
Practical Considerations
- The device is intended to assist manual compression; it does not replace assessment of the access site or treatment of significant vascular complications.
- Use requires appropriate vascular access-site evaluation, including confirmation that the puncture location and vessel anatomy are suitable for closure.
- The FDA record identifies the device category as a vascular clamp under 21 CFR 870.4450; exact device size and compatibility should be confirmed in the current instructions for use.
- MRI safety information is device-specific and should be verified in the current manufacturer labeling before MRI.
- Potential complications include bleeding, hematoma, infection, thrombosis, vessel injury and failure to achieve hemostasis.
Frequently Asked Questions
What are the clinical indications for Boomerang ClosureWire Vascular Closure System?
The device is indicated for vascular closure following diagnostic or interventional procedures, serving as an adjunct to manual compression.
What outcomes have been reported in clinical studies?
Studies report reduced time to hemostasis and earlier patient mobilization compared to manual compression alone.
What complications have been reported?
Reported complications include access site complications, but the device maintains arterial integrity for future interventions.
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.