Boston Scientific's GI balloon dilator gains expanded FDA nod

An illustration of the CRE wireguided balloon dilator--courtesy of Boston Scientific

Boston Scientific ($BSX) won expanded FDA clearance for its CRE wireguided balloon dilator.

Now, physicians can use wield the device to remove stones in the biliary duct, the company disclosed on Tuesday. Its previous indication has been more broad. Regulators previously cleared the device to be used for adult and teen patients to dilate narrow areas in the digestive tract for GI procedures including colonic stent placement, colonoscopy, esophageal stent placement and upper endoscopies, according to the company's website.

Boston Scientific's target for this is significant: More than 60 million patients globally have stones in their common bile duct. And they're hoping for quick adoption in the marketplace, billing it as a more easy-to-use endoscopic therapy choice. It is designed to gradually open areas to help make it easier for endoscopic filming or balloon endoscopies.

In an era of declining margins, device companies, such as Boston Scientific, are seeking new revenue, in part, by boosting approved uses for their devices in markets here and overseas. Boston Scientific, in particular, is also trying to refresh its product offerings with next-generation stents and other products. Earlier this month, the Massachusetts device company stalwart began rolling out its Innova self-expanding bare metal stent system in Europe, following a CE mark there earlier this year.

- read the release

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