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Boston Scientific wins expanded indication from FDA for iliac nerve stent

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Boston Scientific Corp. (NYSE:BSX) won pre-market approval from the Food & Drug Administration to use its Express LD Premounted stent in iliac arteries.

The expanded indication, which the company had expected during the first quarter, should help the Natick, Mass.-based device maker’s sagging peripheral interventions business, which makes stents, balloon catheters, sheaths, wires and vena cava filters used to treat peripheral vascular disease.

The segment posted a 3 percent sales decrease last year, at $661 million compared to $684 million in 2008.

“We definitely see [the new indication clearance] as a boost,” Boston Scientific spokesman Paul Donovan told MassDevice.

The stent is used to treat atherosclerotic iliac disease, which occurs when plaque builds within the arteries that supply blood to the legs, according to a prepared release. The blockages, which can lead to poor blood flow, leg pain and other complications, can be treated with medication, surgery or angioplasty.

The Express LD Iliac Stent has already received CE Mark approval in the European Union.

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