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Medical Devices / Submissions and Approvals

Brightwater’s Biliary Stent System Cleared by FDA

March 26, 2019
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The FDA issued 510(k) clearance for Brightwater Medical’s biliary stent system, designed to remove the need for an invasive procedure in treating biliary duct obstructions.

Used by interventional radiologists, the device enables stent release in less than a minute during an in-office visit or at bedside, eliminating the need for sedation or repeated drain insertions.

The stent system helps to treat biliary duct obstructions, which can lead to serious complications including sepsis, liver damage or biliary cirrhosis.

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