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6 Jun 2013

FDA grants clearance to Cook Medical biliary stent

The new stent has an innovative delivery system that gives clinicians more control.

Cook Medical's new Evolution Biliary Controlled-Release Uncovered Stent has been given 510(k) clearance by the Food and Drug Administration (FDA).

The pharmaceutical agency will therefore extend its gastrointestinal (GI) tract stent product line, potentially allowing it to gain a larger share of the market.

According to the organisation, approximately 35,000 metal biliary stents are utilised each year to combat obstructions in the bile duct.

Blockages in the pathway which carries bile from the liver to the gallbladder and small intestine can lead to symptoms such as cysts, gallstones, and inflammation.

The innovative new product has been designed to maintain its shape and stay firmly in place, ensuring a long-term solution for patients and a lower risk of complications.

Cook Medical's revolutionary delivery system works alongside the medical aid to give doctors ultimate control when inserting the stent, ensuring it can be deployed and recaptured easily.

Global leader of the firm's endoscopy division Barry Slowey said: "Now clinicians can experience the same precision and control throughout the entire GI tract from the esophagus to the colon."

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