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news.Cordis has received 510(k) marketing clearance from the FDA for the SMART Nitinol Stent Transhepatic Biliary System for lengths of 120 mm and 150 mm.
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These stents are indicated for use in the palliative treatment of malignant strictures in the biliary tree that can restrict the flow of digestive fluids and compromise digestion. These stents in the new lengths are available for the first time in the US.
The Nitinol Stent System has demonstrated accurate stent placement, which may decrease the need for additional stents to cover the full narrowing of the bile duct. The safety and effectiveness of this device for use in the vascular system has not been established.