Boston Scientific Corporation has received 510(k) clearance from the U.S. Food and Drug Administration to market its Express Biliary LD pre-mounted stent system for alleviating malignant biliary obstruction. The Company plans to launch the product in the United States immediately.

Malignant biliary obstruction refers to the blockage of any duct that carries bile from the liver to the gallbladder or from the gallbladder to the small intestine. The major symptoms of malignant biliary obstruction result from failure of bile to reach its proper destination -- a condition alleviated by the placement of a stent.

The Express Biliary LD stent system -- developed exclusively by Boston Scientific -- combines proprietary Tandem Architecture stent design with Ultra-thin SDS balloon catheter technology.

Tandem Architecture stent design integrates short, thin Micro elements designed to promote flexibility and conformability, with long, wide Macro elements designed to enhance radial strength and radiopacity. Combined, these elements are designed to enable the Express Biliary LD stent system to conform to the contours of a lumen -- even in tortuous anatomy.

The balloon delivery catheter is a non-compliant balloon catheter featuring SureGrip stent securement technology designed to facilitate deliverability and accurate stent placement. Hydropass hydrophilic coating helps advance the catheter through the tortuous anatomy and the dual-lumen shaft design allows for rapid deflation.

"The Express Biliary LD stent system provides an excellent new therapeutic option," said James Burnes, of Monash Medical Centre in Melbourne, Australia. "It combines good radiopacity, flexibility and ease of insertion in a low-profile, balloon-expandable stent with a wide range of sizes."

"This is an important addition to Boston Scientific's family of balloon-expandable stents," said Paul LaViolette, Boston Scientific Senior Vice President and Group President, Cardiovascular. "We recently launched its coronary counterpart -- the Express2 stent system -- which means we now have highly effective options for multiple patient populations by leveraging the Express stent's unique Tandem Architecture design."