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The Guidant OMNILINK® .018 Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The OMNILINK® .018 Biliary Stent System is a balloon-expandable stent composed of 316L medical grade stainless steel. The stent is pre-mounted onto an over-the-wire (OTW) delivery catheter. The OMNILINK® .018 Biliary Stent System consists of a dual stent design, fabricated from a single piece of 316L medical grade stainless steel tubing. The stent designs are based on a series of zigzagging rings with multiple articulations per ring. The stents are available in two designs which primarily differ in strut width and the length of the basic cell. One design is used for stent sizes 5.0mm - 7.0mm and the other for stent sizes 8.0mm - 10.0mm. The delivery system is an over-the-wire, co-axial design with a balloon at the distal end. delivery catheter's central lumen is designed to permit the use of a 0.018" guide wire to facilitate advancement of the catheter to and through the stricture to be dilated. Once the delivery system is placed in the desired location, the stent expands upon inflating the balloon with contrast medium. The balloon provides an expandable segment of known diameter and length at specific pressures. In addition, the balloon has two radiopaque markers to aid in stent positioning. The stent is designed to remain in the biliary duct as a permanent implant. The subject device OMNILINK® .018 Biliary Stent System consists of stent sizes of diameters ranging from 5.0mm - 10.0mm with stent lengths of 18, 28, 58mm and delivery system length of 80 and 135cm. The stent and delivery system are supplied sterile and is intended for single use only.