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The transGlideXT Expandable Introducer is intended to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries.

The transGlideXT Expandable Introducer (also referred to as "transGlideXT") is the next generation expandable Mesh Introducer consisting of a polymer braid which expands to accommodate catheters and/or devices with profiles up to 22F. The Mesh Introducer, with an indwelling Dilator (also referred to as "Mesh Assembly"), is inserted into the femoral artery, over a 0.035" guidewire (or smaller). The device is introduced at a small diameter of 12F inner diameter (ID) and is designed with a hydrophilic coating on the outer diameter (OD) and ID along the 30 cm usable length, thus facilitating passage through the femoral artery and passage of the commercial catheter and/or device. The proximal 11 cm of the Mesh usable length is sealed to prevent blood loss at the access site. Once at the target location, the Dilator is removed and the Mesh Introducer provides a bearing surface for the commercial catheter and/ or device, which is designed to reduce the axial forces applied to the artery wall while the commercial catheter and/or device is being inserted. The transGlideXT Expandable Introducer is a sterile, non-pyrogenic, single-use prescription device. The transGlideXT Expandable Introducer does not supply but recommends use with commercially available 0.035" (or smaller) Guidewires.

The transGlide Expandable Introducer is intended to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries.

The transGlide Expandable Introducer consists of an expandable Mesh Assembly and a flexible Sheath Assembly. The Mesh Assembly, with an indwelling Dilator, is inserted into the femoral artery over a 0.035" (or smaller) guidewire. The Mesh Assembly is introduced at a small diameter of 13F inner diameter (ID) and is designed with a hydrophilic coating on the outer diameter (OD) of the usable length (effective length), thus facilitating passage through the femoral artery. The proximal 11cm of the Mesh is sealed to prevent blood loss at the access site. Once at the target location, the Mesh Dilator is removed and the Sheath Assembly is inserted, with an indwelling Dilator, through the Mesh Assembly over the guidewire. Prior to removal, the Sheath Assembly is withdrawn through the Mesh Assembly until the Sheath Removal Indicator is visible just proximal to the Docking Port, leaving 8cm of Sheath usable length in place to prevent blood loss while the entire assembly is withdrawn and removed from the patient. The Mesh consists of a polymer braid, which expands to accommodate the profile of the Sheath. The Mesh provides a bearing surface for the Sheath, which is designed to reduce the axial forces applied to the artery wall while the Sheath is being inserted. The Sheath Assembly Dilator is removed leaving a large (16F, 18F or 20F) central lumen extending from the proximal end to the distal end of the Sheath with a usable length of 30cm. The transGlide Expandable Introducer is a sterile, non-pyrogenic, single-use prescription device. The transGlide Expandable Introducer does not supply but recommends use with commercially available 0.035" (or smaller) Guidewires.