Medusa Vascular Plug

FDA-Cleared Indications

• Intended to promote embolization, or intentional blockage, of blood vessels.
• Used when a clinician needs to occlude a selected vessel to control or redirect blood flow.

Clinical Applications

• Embolization of selected visceral arteries or veins when intentional vessel occlusion is required.
• Treatment of aneurysms or pseudoaneurysms as part of a procedure requiring occlusion of the feeding vessel.
• Embolization of abnormal vascular connections or vascular malformations when vessel blockage is clinically indicated.
• Control of bleeding by occluding an identified blood vessel.

Reported off-label uses

• Embolization of ovarian veins for selected patients with pelvic venous disorders.
• Embolization of spermatic veins for selected patients with varicocele.
• Other venous occlusion procedures in which a vascular plug is used outside the 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.

Practical Considerations

• The plug is available in different sizes; the operator must match the device to the target vessel diameter and anatomy.
• It is delivered through a compatible catheter or delivery system under imaging guidance, commonly fluoroscopy and contrast angiography.
• The device is made from a shape-memory polymer that expands against the vessel wall to promote occlusion.
• MRI safety and scan conditions should be confirmed from the current device labeling before an MRI examination; do not assume compatibility from the device name alone.
• Contraindications, vessel anatomy, infection, non-target embolization risk, and the patient's ability to tolerate angiography or sedation must be assessed before treatment.