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reverse medical micro vascular plug mvp system
Reverse Medical
Summary: The Reverse Medical Micro Vascular Plug MVP System is a device used for vascular occlusion. It is primarily used in neurovascular and other vascular pathologies. Key evidence includes successful embolization in complex vascular anomalies.
FDA Clearance Information
Pathway
510K
Number
K133282 ↗
Decision Date
November 27, 2013
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The Reverse Medical Micro Vascular Plug MVP System was cleared by the FDA through the 510(k) pathway on November 27, 2013. It is manufactured by Reverse Medical and classified as a Class 2 device.
What It Is
The Reverse Medical Micro Vascular Plug MVP System is designed for vessel occlusion through targeted embolization. It is used in clinical settings to treat vascular anomalies by obstructing blood flow in specific vessels.
Clinical Applications
Common clinical scenarios for the MVP System include treatment of neurovascular pathologies and congenital vascular anomalies. It is particularly useful in cases requiring precise embolization.
Evidence Summary
The available literature includes three studies, ranging from 2014 to 2022. These studies encompass case reports and technical evaluations, providing insights into the device's clinical applications.
Reported Outcomes
Published studies report successful embolization of complex vascular anomalies, such as congenital intra-hepatic arterioportal fistulas in neonates. The device has shown efficacy in achieving vessel occlusion in neurovascular pathologies.
Safety Profile
Reported complications include typical risks associated with endovascular procedures, although specific adverse events are not detailed in the provided evidence. Overall, the device is considered safe for its intended use.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to fully understand long-term outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for Reverse Medical Micro Vascular Plug MVP 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?
Clinical studies have reported successful embolization in complex vascular cases, such as arterioportal fistulas in neonates.
What complications have been reported?
Reported complications include general risks associated with endovascular procedures, though specific adverse events are not detailed in the evidence.
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.