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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 complex vascular anomalies.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K133282 ↗
Decision Date ?
November 27, 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 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.
FDA-Cleared Indications
- Embolization and occlusion of selected blood vessels when vascular blockage is clinically indicated.
- Use in patients requiring controlled vascular occlusion through a percutaneous catheter-based procedure.
- The device is classified under FDA product code KRD, devices for promoting vascular embolization.
Clinical Applications
- Embolization of selected peripheral vessels, including branches of the visceral and pelvic circulation.
- Occlusion of target vessels associated with aneurysms or pseudoaneurysms when embolization is indicated.
- Vascular embolization procedures requiring controlled blockage of a selected artery or vein.
- Treatment of abnormal or unwanted blood flow in appropriately selected vascular territories.
Reported off-label uses
- Embolization of ovarian veins for pelvic venous disorders.
- Embolization of spermatic veins for varicocele treatment.
- Selected neurovascular or congenital vascular malformation procedures when the device is used outside its specific cleared labeling.
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, 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.
Practical Considerations
- The appropriate MVP size depends on the target vessel diameter, anatomy, blood-flow conditions, and the manufacturer's sizing recommendations.
- The device is delivered through a compatible catheter; sheath, catheter, and wire compatibility should be confirmed before the procedure.
- Deployment requires imaging guidance, typically fluoroscopy with contrast angiography, to confirm position and vessel occlusion before release.
- MRI safety and the conditions for MRI use should be verified in the current device labeling; patients should tell imaging staff that an embolization device is present.
- Potential concerns include non-target embolization, device migration, vessel injury, ischemia, thrombosis, infection, and incomplete occlusion. Contraindications and precautions depend on the target vessel, access route, and patient condition.
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 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.