Transcarotid Stent System, 8 dia. x 40 mm Length, 6 to 7 mm Recommended Vessel Size, 57 cm Working Length, Sterile, Single-Use, Latex-Free, Ethylene Oxide Sterilization, Latex-Free, Ethylene Oxide Sterilization
The ENROUTE transcarotid stent system consists of a nitinol self-expanding stent preloaded on a 5 F (0.065 in./1.65 mm) or 6 Fr (0.078 in./1.98 mm) sheathed delivery system. The rapid exchange delivery system consists mainly of an inner shaft and an outer sheath with radiopaque markers and a Tuohy Borst valve. The inner shaft consists of a support member and wire lumen. The proximal portion of the support member is comprised of a hub connected to a stainless steel wire and hypotube and distally of a stainless steel coil. The wire lumen originates distally in a catheter tip and terminates proximally at a guidewire exit port designed to accept a 0.014 in. (0.36 mm) guidewire. The outer sheath has a proximal shaft and distal outer sheath with a nominal working length of 57 cm. The self expanding ENROUTE transcarotid stent system is constrained within the space between the inner shaft and the distal outer sheath, located between distal and proximal stent markers on the inner shaft. The stent expands to its unconstrained diameter when released from the deployment catheter into the carotid artery. Upon deployment, the stent forms a lattice to cover the diseased arterial segment and pushes outward on the luminal surface, helping to maintain the patency of the artery. Due to the self-expanding behavior of nitinol, the stents are indicated for placement into vessels that are 1 to 2 mm smaller in diameter than the unconstrained diameter of the stent.
