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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 neonates and vessel occlusion in neurovascular conditions.
FDA Clearance Information
Pathway 510K
Number K123803 ↗
Decision Date July 2, 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 July 2, 2013. It is manufactured by Reverse Medical and classified as a Class 2 device under product code KRD.
What It Is
The Reverse Medical Micro Vascular Plug MVP System is designed for endovascular arterial occlusion through targeted embolization. It is used to occlude blood vessels in various clinical scenarios, including neurovascular pathologies.
Clinical Applications
Common clinical scenarios for the MVP System include the treatment of neurovascular pathologies and congenital vascular anomalies. It is used in procedures requiring precise vessel occlusion.
Evidence Summary
The available literature includes three studies, with publication years ranging from 2014 to 2022. These studies encompass case reports and technical evaluations, highlighting the device's application in both neonates and adults.
Reported Outcomes
Published studies report successful embolization of congenital arterioportal fistulas in neonates and effective vessel occlusion in neurovascular pathologies. The device has shown promise in targeted embolization procedures.
Safety Profile
Reported complications include potential risks associated with endovascular procedures, though specific adverse events were not detailed in the provided studies. Overall, the device appears to have a favorable safety profile in the contexts studied.
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 in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Reverse Medical Micro Vascular Plug MVP System?
The device is indicated for vascular occlusion in neurovascular pathologies and congenital vascular anomalies.
What outcomes have been reported in clinical studies?
Studies report successful embolization in neonates and effective vessel occlusion in neurovascular conditions.
What complications have been reported?
Reported complications include general risks associated with endovascular procedures, though specific adverse events were not detailed.
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.