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Reverse Medical Micro Vascular Plug MVP System
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 ?
510(k)
Number ?
K123803 ↗
Decision Date ?
July 2, 2013
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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.
FDA-Cleared Indications
- Endovascular occlusion of selected blood vessels through targeted embolization.
- Use in procedures where controlled vascular occlusion is clinically indicated.
Clinical Applications
- Occlusion of selected visceral arteries or branches during embolization procedures.
- Embolization of selected internal iliac artery branches when vessel occlusion is required.
- Embolization of aneurysms or pseudoaneurysms as part of a treatment plan requiring vessel occlusion.
- Occlusion of selected gonadal or pelvic venous vessels in appropriately planned embolization procedures.
Reported off-label uses
- Occlusion of selected vessels in neurovascular embolization procedures when the device's size, delivery system and labeling are appropriate.
- Embolization of selected congenital or acquired vascular anomalies in specialized clinical practice.
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. 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.
Practical Considerations
- The device is delivered through a compatible catheter; the treating physician must select the device and catheter sizes based on vessel diameter, anatomy and blood-flow conditions.
- Accurate angiographic imaging is used to confirm the target vessel, device position and vessel occlusion before and after deployment.
- Potential complications include nontarget embolization, vessel injury, ischemia, bleeding, infection, device migration and incomplete occlusion.
- MRI safety and MRI conditions should be confirmed in the current manufacturer labeling; do not assume that an implanted or retained device is MR Safe without documentation.
- Contraindications and warnings include unsuitable vessel anatomy, inability to safely reach the target, high-flow conditions that could cause migration, and known incompatibility with the delivery system or contrast materials used in the procedure.
Procedures that use this device
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.