DEVICE: Niti-S Esophageal Stent (08809233103012)

Device Description: The Niti-S Esophageal Stent intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors. The Niti-S Esophageal Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible, expandable tubular device woven from one or two continuous pieces of Nitinol wire to avoid sharp edges. At each end, the stent has a larger diameter resulting in a “dumbbell” shaped stent when viewed from an axial cross-section. The Niti-S Esophageal Stent is provided in three configurations: the Uncovered type, the Full Covered type and the Both Bare type. The Uncovered-type stent is available in two diameters (6, 8mm), and five lengths (60, 80, 100, 120, and 150mm). The Full Covered-type and the Both Bare-type stents are available in three diameters (6, 8, 10mm), and five lengths (60, 80, 100, 120, and 150mm). It has 10 radiopaque markers. This device also includes a disposable introducer. Upon deployment, the stent imparts an outward radial force on the luminal surface esophagus to establish patency. The introducer system consists of an Inner Catheter, Outer Sheath, Hub, Y-connector, Tip and Pusher. All of the components of the introducers are supplied sterile in a disposable package. The usable lengths of the introducer is 70cm. Other information: The shelf-life of Niti-S Esophageal Stent is 3 years. The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.038 inch (0.97mm). Do not use if package is damaged. Do not reuse or resterilize.