Mreye Flipper Detachable Embolization Coil and Delivery System

FDA-Cleared Indications

• Embolization and occlusion of blood vessels when intentional blockage of blood flow is clinically required.
• Use in interventional procedures in which a detachable coil is selected to promote vascular embolization.

Clinical Applications

• Occlusion of selected blood vessels during minimally invasive embolization procedures.
• Treatment of vascular abnormalities or bleeding when vessel embolization is part of the planned procedure.
• Use in interventional radiology or vascular surgery procedures requiring controlled coil deployment through a catheter.

Reported off-label uses

• Embolization of selected visceral, pelvic, or peripheral vessels in clinical situations not specifically described in the available FDA summary.
• Adjunctive vessel occlusion during treatment of aneurysms, pseudoaneurysms, arteriovenous malformations, or hemorrhage when the specific application is outside the device 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.

Practical Considerations

• The coil is delivered through a catheter and detached only after the operator confirms its position at the target vessel.
• Available coil sizes and delivery-system specifications must match the target-vessel diameter, anatomy, and catheter compatibility.
• The device should not be released until positioning and stability have been evaluated with fluoroscopic imaging.
• MRI safety depends on the specific device labeling and configuration; the current FDA record or manufacturer instructions should be checked before MRI.
• Potential concerns include non-target embolization, vessel injury, coil migration, incomplete occlusion, thrombosis, bleeding, infection, and complications related to vascular access or contrast.