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Azur Vascular Plug
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 ?
510(k)
Number ?
K191680 ↗
Decision Date ?
March 20, 2020
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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.
FDA-Cleared Indications
- Promotes embolization by occluding selected blood vessels.
- Used for endovascular control of blood flow in peripheral and visceral vessels.
- Intended for use under image guidance by trained clinicians.
Clinical Applications
- Embolization of selected visceral arteries and branches.
- Treatment of selected visceral artery aneurysms and pseudoaneurysms.
- Internal iliac artery embolization when vessel occlusion is required.
- Splenic artery embolization for appropriately selected indications.
- Embolization of pelvic venous vessels, including ovarian or gonadal veins, when the device size and anatomy are suitable.
Reported off-label uses
- Embolization of pulmonary arteriovenous malformations and other pulmonary vascular abnormalities.
- Embolization for selected gastrointestinal bleeding when other treatment options are unsuitable or unsuccessful.
- Embolization of varicoceles and pelvic venous congestion syndromes.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The plug is available in multiple diameters and lengths; sizing must account for the target vessel diameter, vessel shape, flow, and the manufacturer's sizing recommendations.
- It is delivered through a compatible catheter or sheath under fluoroscopic or other image guidance. Vessel access is commonly obtained through the femoral or radial artery, depending on the procedure.
- The device is intended for controlled vessel occlusion and should not be deployed until the operator confirms the target position and adequate landing zone.
- MRI safety and scanning conditions depend on the specific Azur Vascular Plug model and its current labeling. The exact model and implant conditions should be confirmed before MRI.
- Potential concerns include non-target embolization, device migration, incomplete occlusion, vessel injury, ischemia, infection, bleeding at the access site, and contrast or anesthesia-related complications.
Procedures that use this device
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.