Boston Scientific’s CRE Wireguided Balloon Dilator receives new approval

Boston Scientific has been granted approval for its CRE Wireguided Balloon Dilator to be used in an expanded indication.

The US Food and Drug Administration has ratified the device for endoscopic dilation of the sphincter of Oddi following sphincterotomy, allowing physicians to perform dilation-assisted stone extractions.

This alternative method for the removal of difficult stones in the biliary duct can be completed rapidly using the Boston Scientific device, thanks to its easy-to-place nature, its consistency and reliability.

Constructed using Pebax to provide durability and flexibility, the CRE Wireguided Balloon Dilator can gradually open strictures by delivering three distinct pressure-controlled diameters in a single balloon, while its rounded-shoulder design offers greater ease of use.

David Pierce, president of the endoscopy division at Boston Scientific, said: "The CRE Wireguided Balloon Dilator is a core product in our endoscopy portfolio and it underscores our ongoing commitment to advancing treatments that meet the needs of patients and physicians."

This follows the European launch of the company's Emerge percutaneous transluminal coronary angioplasty dilatation catheter last month.