Boston Scientific's Advanix Biliary Plastic Stents receive FDA 510(k) clearance and CE Mark approval

Boston Scientific Corporation (NYSE: BSX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval to market its Advanix™ Biliary Plastic Stents for the treatment of biliary strictures, including biliary stone disease, benign biliary strictures, and suspected and confirmed malignancies in the biliary system.  The product is now available in Europe and other international markets; the Company plans to launch it in the U.S. this quarter.

Endoscopic therapy, specifically with stent placement, has gained acceptance as a first line of treatment for biliary strictures and offers a less-invasive alternative to surgery.  Results from a published study of patients with post-operative benign bile duct strictures demonstrated that stenting has similar long-term success rates and lower early complication rates compared to surgery.

The Advanix Biliary Stent is designed to accommodate a range of clinical requirements and includes features for improved deliverability in navigating tortuous anatomy.  It employs the NaviFlex™ RX Delivery System, which offers physicians the flexibility to employ both long-wire and short-wire guidewires during access and stent placement.  The pre-loaded stent within the delivery system enables physicians to reposition the stent, helping to ensure accurate placement.  The highly visible guidewire exit port allows for easier manipulation during the procedure.

"The Advanix Biliary Stent System features significant developments in plastic stent technology," said Stuart Sherman, M.D., Clinical Director of Gastroenterology and Hepatology, and Director of the ERCP program at Indiana University Medical Center in Indianapolis.  "Improvements in design provide greater procedural control and efficiency while navigating tight strictures in the bile ducts, facilitating stent placement and removal.  The thin wall and increased inner diameter of the stent may provide extended patency of the duct, which could improve treatment outcomes."

"Boston Scientific remains committed to delivering innovation and leadership in endoscopic stent technology," said Michael Phalen, Senior Vice President, and President of Boston Scientific's Endoscopy Division.  "The Advanix Biliary Stent System represents the latest advances in plastic stent design, enabling physicians to more efficiently and effectively treat blockages in the bile duct.  In addition, it strengthens our broad stent portfolio and provides another solution for the ERCP suite."

Benign strictures in the bile duct are typically caused by prior surgical procedures, biliary stones or chronic pancreatitis, a disease in which digestive enzymes begin to break down and attack the pancreas.  Chronic pancreatitis is extremely painful and in severe cases, can lead to infection, shock and respiratory failure.  The most common cause of malignant biliary obstruction is pancreatic cancer, which is rarely diagnosed in the early stages, and is the second most common cause of death among gastrointestinal cancers.  Other causes of malignant biliary obstructions include bile duct, liver and gallbladder cancer.  

The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of sizes and shapes to accommodate both malignant and benign biliary strictures, distinct patient anatomies and physician preferences.