
Boston Scientific Corp. announced today that the first patient has been enrolled in a clinical trial to determine if a stent used for malignant bile duct strictures can also be used for the treatment of benign bile duct strictures.
Boston Scientific (NYSE:BSX), a Natick-based medical device maker, will study the so-called WallFlex Biliary RX Fully Covered Stent in a multi-center trial that includes 187 patients at 11 centers worldwide over the next 18 months.
A bile duct stricture is an abnormal narrowing of the common bile duct. Risk factors include prior surgery, pancreatitis, trauma and gallstones. Patients with this condition often experience jaundice, fever, chills and abdominal pain.
The study will include patients with bile duct strictures following liver transplants, gall bladder removal surgery and chronic pancreatitis.
The WallFlex Biliary RX Stent will remain in the patients for four to 12 months, depending on the nature of the stricture. Researchers will follow patients for five years after stent removal.
The WallFlex Biliary RX Stents are currently approved in the U.S. and in Europe for the treatment of malignant bile duct strictures.
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