Premere Delivery Sheath Model Pds

FDA-Cleared Indications

• Delivery of embolization coils for the occlusion of blood vessels.
• Use during endovascular procedures in which a blood vessel must be intentionally blocked.

Clinical Applications

• Delivering embolization coils to a target blood vessel.
• Supporting endovascular treatment of aneurysms when coil occlusion is indicated.
• Supporting embolization of abnormal vascular connections or malformations when coil occlusion is indicated.
• Controlling or stopping blood flow in a selected vessel during an embolization procedure.

Reported off-label uses

• Use of a delivery sheath of this type with embolic materials or procedural applications not specifically included in its FDA-cleared labeling may occur in clinical practice, but such use is physician-directed and off-label.

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 appropriate sheath size depends on the target vessel, vascular access route, anatomy, and the dimensions of the intended embolization coil.
• The sheath should be used with compatible embolization coils and other accessories according to the device labeling and institutional protocols.
• Placement is performed under fluoroscopic or other appropriate image guidance by clinicians trained in vascular catheterization and embolization.
• The FDA record provided does not establish MRI safety; MRI conditions should be confirmed in the current manufacturer labeling before scanning a patient with the device in place.
• General contraindications and risks include unsuitable vascular anatomy, inability to safely access the target vessel, vessel injury, bleeding, infection, clot formation, non-target embolization, and device-related complications.