Bile Stenting System Blessed
The Complete SE (self-expanding) Biliary Stent System, designed and manufactured by Medtronic, received marketing clearance from the Food and Drug Administration (FDA) as described in a company press release. The product is intended for use in patients with cancer of the biliary tree as palliative treatment option.
The stent is available in sizes ranging from 4 - 10 mm in diameter and 20 - 150 mm in length. The purpose of the stent is to clear blockage of the ducts which impair digestive processes, specifically the flow of digestive fluid into the intestine. Tumors in the area can impede those ducts.
Basic research studies suggest that the study has a high level of accuracy in stent placement. The accuracy of initial stent placement reduces the likelihood that stents to cover the remainder narrowing of the duct will be required in the future.
The company plans to commence device sales immediately.
November 20, 2007 Related topics: Product Approval & Certification, New Technology & Innovation, Surgery, Gastroenterology