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Reverse Medical Micro Vascular Plug System
Product: MVP — all models and sizes
Summary: The Reverse Medical Micro Vascular Plug System is a device used for vascular occlusion. It is primarily used in neurovascular and other vascular pathologies. Key evidence includes successful embolization in a neonate and vessel occlusion in neurovascular pathologies.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K150108 ↗
Decision Date ?
April 22, 2015
Product Code ?
KRD Device, Vascular, For Promoting Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The Reverse Medical Micro Vascular Plug System was cleared by the FDA via the 510(k) pathway on April 22, 2015. It is manufactured by Reverse Medical and is classified as a Class 2 device under product code KRD.
What It Is
The Reverse Medical Micro Vascular Plug System is designed for endovascular arterial occlusion through targeted embolization. It is used in clinical applications requiring vessel occlusion, such as treating neurovascular pathologies.
FDA-Cleared Indications
- Embolization and occlusion of blood vessels during endovascular procedures.
- Use in vascular anatomy where a small, targeted occlusion is needed.
- Intended for use by trained physicians under imaging guidance.
Clinical Applications
- Targeted occlusion of selected arteries or veins during embolization procedures.
- Treatment of vascular lesions or abnormal vessels when vessel sacrifice is clinically appropriate.
- Embolization of congenital or acquired vascular abnormalities requiring precise vessel occlusion.
Reported off-label uses
- Embolization of selected visceral, pelvic, or gonadal vessels when the treating physician determines that the device is appropriate.
- Use in some neurovascular embolization procedures beyond the specific situations described in the device labeling.
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 three studies, with publication years ranging from 2014 to 2022. The studies encompass case reports and technical evaluations, providing insights into the device's application in both neonatal and neurovascular contexts.
Reported Outcomes
Published studies report successful embolization of a congenital intra-hepatic arterioportal fistula in a neonate using the MVP Microvascular Plug system. Additionally, the device has been used for vessel occlusion in neurovascular pathologies, demonstrating its efficacy in targeted embolization.
Safety Profile
Reported complications include no specific adverse events or complications detailed in the provided studies. The safety profile appears favorable based on the limited available evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and safety across diverse patient populations.
Practical Considerations
- The device is delivered through a compatible catheter under fluoroscopic or other imaging guidance; the appropriate catheter size and access route depend on the target vessel and device model.
- The operator must confirm that the vessel diameter, landing zone, and anatomy are suitable before deployment.
- Potential contraindications include inability to safely catheterize the target vessel, an unsuitable vessel size or landing zone, uncorrectable bleeding risk, or an active infection at the access site.
- MRI safety depends on the current device labeling and the exact implanted configuration. Confirm MR conditions with the manufacturer and radiology department before an MRI.
- After deployment, retrieval or repositioning may not be possible; the device is intended to provide durable vessel occlusion.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Reverse Medical Micro Vascular Plug System?
The device is indicated for use in vascular occlusion, particularly in neurovascular pathologies and congenital vascular anomalies.
What outcomes have been reported in clinical studies?
Studies have reported successful embolization in a neonate with a congenital arterioportal fistula and effective vessel occlusion in neurovascular pathologies.
What complications have been reported?
The provided evidence does not detail specific complications, suggesting a favorable safety profile, though further research is needed.
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.