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The Medtronic, Inc. RACER Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

The RACER Biliary Stent System consists of a MP35N (Cobalt, Nickel, Chromium, Molybdenum Alloy) stent mounted on an over-the-wire delivery system. The device is equipped with an AV100 balloon mounted on the distal portion of the catheter. Diameters of the device include 4.0, 5.0, 6.0, and 7.0mm and the lengths are either 12mm or 18mm, all premounted on 80cm or 130cm catheters.

The Bridge Constant Biliary Stent System is indicated for use in the palliation of malignant neoplasm in the biliary tree.

The subject device is a single use only device with a stent mounted on an over-the-wire delivery system. The device is equipped with an A V100 balloon mounted on the distal portion of the catheter to facilitate the percutaneous delivery of the stent.

The Aurora is indicated for use in the palliation of malignant neoplasm in the biliary tree.

The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium ("nitinol") stent pre-loaded onto a sheathed delivery catheter. The stent design and catheter incorporate radiopaque markers to aid in stent placement during fluoroscopy. The delivery system is designed to deliver the stent to the stricture site. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent's expansion results in the opening of the constructed lumen within the biliary tree.

The Aurora is indicated for use in the palliation of malignant neoplasm in the biliary tree.

The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium (“nitinol”) stent pre-loaded onto a sheathed delivery catheter. The stent design incorporates radiopaque markers to aid in stent placement during fluoroscopy. The delivery system is designed to deliver the stent to the stricture site. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent expands and conforms to the inner lumen of the biliary duct. Two catheter mounted radiopaque markers aid in visibility during fluoroscopy.

The Bridge SE Biliary Self-Expanding Stent Delivery System is indicated for use in the palliation of malignant neoplasm in the biliary tree.

The subject device is a system consisting of a single-lumen, tubular, self-expanding nickel-titanium ("nitinol") stent pre-loaded onto a sheathed delivery catheter. The delivery system is designed to deliver the stent to the stricture site via transhepatic access. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent expands and conforms to the inner lumen of the biliary duct. The device has two radiopaque markers to aid in stent placement during fluoroscopy.

The Medtronic AVE Bridge™ FX Biliary Stent Delivery System is intended to maintain patency of a bile duct, which is occluded by a malignant tumor.

The Bridge FX Stent Delivery System consists of a balloon-expandable intralumenal, 316L stainless steel stent pre-mounted onto the balloon of an over-the-wire delivery catheter. The device is available in diameters ranging from 6-10 mm and in several lengths including 20, 30, 40, and 60 mm. The delivery system has two radiopaque marker bands to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has useable lengths of 80 and 130 cm. The device is provided in a sterile package.

The Medtronic AVE Solstice™ Solstice Balloon Temporary Occlusion System is intended to be used for temporary vascular occlusion in selectively stopping or controlling blood flow in the peripheral, cerebral, and visceral vasculature.

The Solstice is a single lumen balloon catheter that uses the QS 10 guidewire to occlude the central lumen and allow inflation of the balloon. This is accomplished by advancing any part of the QS 10 through the catheter. The single lumen then becomes occluded allowing fluid to fill the balloon.