Gore Dryseal Sheath

FDA-Cleared Indications

• Provides vascular access for the introduction of endovascular devices.
• Supports procedures requiring large-bore access and repeated device exchanges.
• Used to facilitate delivery of endovascular devices through tortuous or challenging vascular anatomy.

Clinical Applications

• Access for transcatheter valve implantation procedures.
• Vascular access for transcatheter pulmonary valve implantation.
• Large-bore access during complex percutaneous cardiovascular interventions.
• Maintaining a stable conduit during procedures involving severe iliofemoral tortuosity.

Reported off-label uses

• Large-bore access for selected structural-heart, aortic, and peripheral endovascular procedures when the sheath size and anatomy are appropriate.
• Access for selected embolization or endovascular interventions requiring device exchanges through a larger sheath.

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, working lengths, and inner diameters vary by model; the selected sheath must match the delivery system and the patient's vessel size.
• Usually inserted over a guidewire through a percutaneous femoral or other suitable arterial access site under fluoroscopic or ultrasound guidance.
• The sheath is compatible only with devices that fit its inner diameter and length; valve and other delivery-system requirements should be checked before the procedure.
• Potential complications include bleeding, hematoma, vessel injury, thrombosis, dissection, perforation, infection, and limb ischemia.
• MRI safety depends on the exact model and whether the sheath is still present; the current product labeling should be checked before MRI. The device is generally intended for temporary procedural use, not permanent implantation.