đź“Š Evidence-Based Reference
boomerang closurewire vascular closure system
Cardiva Medical
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 510K
Number K051817 ↗
Decision Date December 6, 2006
Product Code DXC
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.
Clinical Applications
Commonly used in scenarios requiring vascular access management, the device is applied post-procedures such as angiography to aid in closure and reduce time to hemostasis. It is particularly relevant in settings where early patient mobilization is desired.
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.
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.