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azur vascular plug
Microvention
Summary: The Azur Vascular Plug is a device used for vascular embolization. It is primarily used in managing vascular malformations and controlling bleeding. Key evidence includes its use in complex cases involving pulmonary hypertension and gastrointestinal bleeding.
FDA Clearance Information
Pathway 510K
Number K191680 ↗
Decision Date March 20, 2020
Product Code KRD
Device Class Class 2
Evidence 0 studies
The Azur Vascular Plug was cleared by the FDA via the 510(k) pathway on March 20, 2020. It is manufactured by Microvention and is classified as a Class 2 medical device.
What It Is
The Azur Vascular Plug is a vascular embolization device designed to occlude blood vessels. It is used in clinical settings to manage vascular malformations and control hemorrhage by blocking blood flow to specific areas.
Clinical Applications
Common clinical scenarios for the Azur Vascular Plug include the treatment of arteriovenous malformations and the management of bleeding in gastrointestinal and other vascular conditions. It is often used when endoscopic or surgical interventions are not feasible.
Evidence Summary
The available literature includes two studies: a case report from 2011 and a case series from 2025. These studies highlight the device's application in complex clinical scenarios, such as pulmonary hypertension and gastrointestinal bleeding.
Reported Outcomes
Published studies report successful embolization of vascular malformations and control of bleeding using the Azur Vascular Plug. In one case, it was part of a stepwise management approach for pulmonary hypertension in an infant, while another study demonstrated its efficacy in treating a bleeding duodenal ulcer.
Safety Profile
Reported complications include the potential for incomplete vessel occlusion and migration of the device. However, the studies provided do not detail specific adverse events directly associated with the Azur Vascular Plug.
Evidence Limitations
The evidence is limited to case reports and series, which may not provide comprehensive safety and efficacy data. Further research with larger sample sizes and controlled trials is needed to establish broader clinical guidelines.
Frequently Asked Questions
What are the clinical indications for Azur Vascular Plug?
The Azur Vascular Plug is indicated for vascular embolization in conditions such as arteriovenous malformations and to control bleeding in various clinical scenarios.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful embolization and control of bleeding in complex cases, including pulmonary hypertension and gastrointestinal bleeding.
What complications have been reported?
Reported complications include incomplete vessel occlusion and potential device migration, though specific adverse events are not detailed in the provided studies.
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.