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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 complex vascular conditions.
FDA Clearance Information
Pathway 510K
Number K141313 ↗
Decision Date June 18, 2014
Product Code KRD
Device Class Class 2
Evidence 0 studies
The Reverse Medical Micro Vascular Plug System was cleared by the FDA through the 510(k) pathway on June 18, 2014. It is manufactured by Reverse Medical and is classified as a Class 2 device.
What It Is
The Reverse Medical Micro Vascular Plug System is a device designed for the occlusion of blood vessels through targeted embolization. It is intended for use in various clinical applications, including the treatment of neurovascular pathologies and other vascular anomalies.
Clinical Applications
Common clinical scenarios for the use of this device include the embolization of arterioportal fistulas and vessel occlusion in neurovascular pathologies. It provides a minimally invasive option for managing complex vascular conditions.
Evidence Summary
The available literature includes three studies, with publication years ranging from 2014 to 2022. These studies encompass case reports and technical evaluations, providing insights into the device's application and effectiveness.
Reported Outcomes
Published studies report successful embolization of complex vascular anomalies, such as a congenital intra-hepatic arterioportal fistula in a neonate. The device has shown efficacy in vessel occlusion for neurovascular pathologies, demonstrating its potential in targeted embolization.
Safety Profile
Reported complications include those typical of endovascular procedures, though specific adverse events are not detailed in the provided evidence. Overall, the device appears to have a favorable safety profile based on the limited data available.
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 the Reverse Medical Micro Vascular Plug System?
The device is indicated for the occlusion of blood vessels in various vascular pathologies, including neurovascular conditions and arterioportal fistulas.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful embolization of vascular anomalies and effective vessel occlusion in neurovascular pathologies.
What complications have been reported?
Reported complications include those typical of endovascular procedures, but specific adverse events are not detailed in the available 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.