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Reverse Medical Micro Vascular Plug System
Product: MVP — all models and sizes
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 ?
510(k)
Number ?
K141313 ↗
Decision Date ?
June 18, 2014
Product Code ?
KRD Device, Vascular, For Promoting Embolization
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.
FDA-Cleared Indications
- Occlusion of selected blood vessels by endovascular embolization.
- Treatment of arterioportal fistulas.
- Use in neurovascular and other vascular applications where controlled vessel occlusion is indicated.
Clinical Applications
- Embolization of arterioportal fistulas.
- Targeted occlusion of vessels involved in neurovascular pathologies.
- Endovascular treatment of selected vascular anomalies requiring vessel occlusion.
Reported off-label uses
- Embolization of selected visceral artery aneurysms or pseudoaneurysms.
- Internal iliac artery embolization for selected pelvic bleeding or preoperative indications.
- Ovarian vein embolization for pelvic venous disorders.
- Varicocele embolization.
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, 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.
Practical Considerations
- The plug is delivered through a compatible catheter, with size selection based on the target vessel diameter, anatomy and desired degree of occlusion.
- The procedure is performed under fluoroscopic or other appropriate imaging guidance, usually through percutaneous vascular access.
- Users should confirm catheter compatibility, deployment requirements and the instructions for use for the specific plug size before placement.
- MRI conditions and artifact information should be confirmed in the current manufacturer labeling; do not assume MRI safety from the device category alone.
- Potential contraindications and risks include unsuitable vascular anatomy, inability to safely reach the target vessel, non-target embolization, vessel injury, ischemia and access-site complications.
Procedures that use this device
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.