BSX shares peaked at $9.03 apiece today, their highest point since October 2009, after the Natick, Mass.-based company reported the enrollment of the 1st patient in a 294-subject clinical trial of the WallFlex device.
The study will compare using the WallFlex self-expanding stent before pancreatic cancer surgery with surgery without stent drainage, according to a press release.
"Patients with pancreatic or periampullary cancer often have high levels of bilirubin, which adversely affect their liver, cardiovascular and renal functions," Dr. Jacques Deviere of Erasme Hospital in Brussels said in prepared remarks. "These patients often have impaired immune response and clotting, which in turn could negatively impact the outcome of their surgical resection. Preoperative biliary drainage could potentially reverse these factors and therefore result in an improved outcome of the surgery. Published data regarding plastic stent drainage prior to surgical resection have been unfavorable and physicians are increasingly turning to self-expanding metal stents for preoperative drainage where necessary due to their large diameter. We expect this study to provide us with important data on the safety and effectiveness of this approach compared with proceeding to surgery without biliary drainage."
"Boston Scientific is committed to advancing science through investment in robust clinical research, while delivering innovative technologies designed to improve quality of life for patients," added Boston Scientific endoscopy president David Pierce in a prepared statement. "The results of this study may indicate that using SEMS preoperatively for biliary drainage could result in better patient outcomes and prove to be more cost effective for physicians and hospitals."
Boston Scientific said the study will include 2 versions of the WallFlex stent, the fully covered and uncovered models. The fully-covered stent has a silicone polymer coating designed to prevent tissue ingrowth and a built-in loop for repositioning or removing the device, according to the release.
The company won 510(k) approval in October 2009 for the palliative treatment of malignant bile duct strictures using the WallFlex devices, adding an expanded CE Mark approval in the European Union a year later for the treatment of benign biliary strictures. Last December Boston Scientific launched another trial of the WallFlex, comparing it with plastic stents in treating biliary strictures.
BSX shares are up 14.8% since May 8, just before it announced study results showing that its Watchman heart implant is superior to the anticoagulant drug Warfarin. Shares were trading at $9.02 each as of about 1:40 p.m. today, up 3.7%.