Edwards Esheath Optima Introducer Set

FDA-Cleared Indications

• Facilitates placement of embolization coils within the vasculature.

Clinical Applications

• Vascular access for procedures that place embolization coils.
• Access during endovascular treatment of selected aneurysms.
• Access during embolization of selected vascular malformations.

Reported off-label uses

• Use as an access sheath for delivery of other compatible embolization devices or interventional catheters may occur in clinical practice, but this should not be assumed to be FDA-cleared for this specific device.

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

• Available sizes and usable lengths should be selected according to the target vessel, access route, anatomy, and embolization device requirements.
• The sheath and dilator must be compatible with the intended catheter, coil-delivery system, guidewire, and other procedural equipment.
• Use requires sterile technique, imaging guidance, and trained vascular-interventional personnel.
• Potential access-related complications include bleeding, hematoma, vessel injury, thrombosis, infection, and contrast or embolic complications related to the underlying procedure.
• MRI compatibility and conditions should be confirmed in the current Edwards labeling before MRI examination; do not assume the set is safe in an MR environment.