Home » J&J Company Receives Clearance for Stent Biliary System
J&J Company Receives Clearance for Stent Biliary System
Cordis, a subsidiary of Johnson & Johnson (J&J), has received 510(k) marketing clearance from the FDA for the SMART Nitinol stent transhepatic biliary system for stent lengths of 120 and 150 mm.
The stents are to treat malignant strictures in the biliary tree that can restrict the flow of digestive fluids and compromise digestion, according to J&J.
The stents have demonstrated accurate placement, which may decrease the need for additional stents. However, the safety and effectiveness of this device for use in the vascular system have not been established.
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