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reverse medical micro vascular plug system
Reverse Medical
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 510K
Number K150108 ↗
Decision Date April 22, 2015
Product Code KRD
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.
Clinical Applications
Common clinical scenarios for this device include the treatment of neurovascular pathologies and congenital vascular anomalies. It is particularly useful in scenarios requiring precise embolization to occlude blood vessels.
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.
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.