Gore Dryseal Sheath

FDA-Cleared Indications

• Access to the vascular system for the introduction of diagnostic or interventional devices.
• Maintaining vascular access during endovascular procedures.
• Use with compatible intravascular devices in procedures requiring a hemostatic valve and large-bore access.

Clinical Applications

• Providing vascular access for endovascular device introduction.
• Maintaining access during catheter-based vascular interventions.
• Facilitating procedures in which repeated device exchanges are required through a stable sheath.
• Providing hemostatic access during procedures that use compatible large-diameter catheters or delivery systems.

Reported off-label uses

• Use as an access sheath for selected embolization procedures when the sheath size and device compatibility are appropriate.
• Use for complex arterial or venous interventions not specifically described in the device labeling, based on operator judgment and institutional practice.

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 lengths vary by model; the sheath must match the planned catheter, delivery system, guidewire, and vessel diameter.
• The access site and sheath size should be selected after considering vessel caliber, tortuosity, calcification, thrombosis risk, and the need for hemostasis.
• Use fluoroscopic or other appropriate imaging guidance and follow the manufacturer's instructions for insertion, flushing, device exchange, and removal.
• Potential complications include bleeding, hematoma, vessel injury, thrombosis, embolization, infection, and distal ischemia.
• The sheath itself is not the component being imaged by MRI; MRI safety depends on the specific model, whether it remains in place, and the manufacturer's current labeling. Confirm conditions before MRI.