Boston Scientific Introduces "Platinum Standard" In Biliary Metal Stenting With International Launch Of Wallflex® Biliary Rx Stenting System

Main Category: Medical Devices / Diagnostics
Also Included In: GastroIntestinal / Gastroenterology
Article Date: 17 Oct 2008 - 4:00 PDT

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Boston Scientific Corporation (NYSE: BSX) today announced the European availability of the WallFlex® Biliary RX Stent for the palliative treatment of malignant common bile duct strictures. The WallFlex Stent is designed specifically to provide luminal patency through improved stent flexibility and control, allowing more precise stent placement. The WallFlex Biliary Stent System is being demonstrated at the United European Gastroenterology Week® (UEGW) meeting, which is being held on October 18-22 in Vienna.

WallFlex Biliary Stents are designed to accommodate a range of anatomical and clinical requirements and are now available in Europe in fully covered, partially covered and uncovered models. The WallFlex Biliary RX uncovered stent received U.S. Food and Drug Administration clearance on September 1, 2006 and is the only WallFlex Biliary Stent model cleared for use in the United States.

Pancreatic cancer is the most common cause of malignant biliary obstructions and is the second most common cause of death from cancer with an estimated 232,000 new cases each year and a mortality incidence ratio of 98 percent worldwide(2). Other causes of malignant biliary obstructions include bile duct, liver and gallbladder cancer. Approximately 70 percent of patients with a malignant bile duct obstruction are poor candidates for surgery because the cancer has spread(3). With these cases, palliative treatment can improve the patient's quality of life by controlling the symptoms and complications of this disease.

Studies show that metal stent placement is most effective for palliative treatment of inoperable malignant common bile duct strictures(4). The WallFlex Biliary RX Stent is designed to offer the benefits of prior generation stents, such as the industry-leading WALLSTENT® Endoprosthesis, while incorporating new features based on extensive research and clinician feedback. WallFlex is developed with a proprietary platinum-cored Nitinol construction. This unique Platinol™ wire provides greater flexibility -- 30 percent more flexible than WALLSTENT Endoprosthesis -- to better aid in stent placement within tortuous anatomies. The enhanced full length radiopacity offered by Platinol wire and the multiple marker delivery system are designed to provide more precise stent placement, while the radial force of WallFlex is designed to maintain patency and resist migration(5,6).

WallFlex Biliary RX Stents also feature a closed cell construction designed to resist tissue ingrowth5, looped ends intended to reduce the risk of tissue trauma, and flared ends intended to reduce the risk of stent migration. The proprietary durable silastic polymer (Permalume®) covering of the fully and partially covered stents is designed to reduce the potential for tumor ingrowth. In addition, WallFlex incorporates an integrated retrieval loop for removal during the initial stent placement procedure, to be used in the event of incorrect placement.

"The WallFlex Biliary RX Stents appear to overcome key limitations of traditional biliary stent offerings," said Professor Guido Costamagna, M.D., Head of Digestive Endoscopy at Università Cattolica del Sacro Cuore, Policlinico A. Gemelli in Rome, Italy and Primary Investigator for the WallFlex partially covered stent study. "We are encouraged that these new devices will allow increased precision in stent placement while potentially reducing the problem of stent migration."

"As the market leader in biliary stenting for 17 years, Boston Scientific is committed to improving the technology used to diagnose, palliate and treat digestive diseases," said David McFaul, Boston Scientific Senior Vice President, International. "Building on the market-leading success of WALLSTENT, we are pleased to deliver the new 'Platinum Standard'(1) for the treatment of malignant common bile duct strictures. Developed with the needs of our physicians in mind, the WallFlex Biliary RX System provides greater flexibility and resistance to ingrowth and migration than previous stenting platforms such as WALLSTENT."

Notes:

(1) WallFlex is developed with a proprietary platinum-cored Nitinol construction

(2) JAMA and Archives Journals (2007, January 17). Chemotherapy Appears To Delay Cancer Recurrence Following Surgery For Pancreatic Cancer. ScienceDaily. Retrieved October 7, 2008, from http://www.sciencedaily.com/releases/2007/01/070116205541.htm

(3) Mahesh Kumar Neelala Anand, Pancreas, Adenocarcinoma. http://www.emedicine.com/

(4) Kassis et al. Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. GI Endoscopy, 2003; 57: 178-182

(5) Moss A.; Morris E.; MacMathuna P.; Palliative biliary stents for obstructing pancreatic carcinoma. Cochrane Database Systematic Review, 25 Jan. 2006.

(6) Soderlund K., Linder S.; Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointestinal Endoscopy, 2006; 63: 986-995.

Presentations at UEGW

Dr. Costamagna will present safety and effectiveness results from a 70 patient WallFlex Stent study titled, "A Multi-Center, Single Arm, Prospective Study of a New Partially Covered Nitinol Self-Expanding Stent for the Palliative Treatment of Malignant Bile Duct Obstruction" at UEGW during the Free Paper Session "Efficacy of therapeutic ERCP" on Monday, October 20 from 15:35-17:05 in Hall F1.

In addition, Boston Scientific will host a breakfast symposium titled, "ERCP: Changing Algorithms, Changing Outcomes" to discuss developments in biliary stenting and advances in ERCP featuring SpyGlass Direct Visualization System for single-operator duodenoscope assisted cholangiopancreatoscopy, which will take place at UEGW on Tuesday, October 21 from 7:00 to 8:00 in Hall F2.

About Boston Scientific

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.

About Boston Scientific Endoscopy

Boston Scientific Endoscopy develops innovative technology for less invasive, more efficient gastrointestinal procedures. We stand beside our physicians, surgeons and nurses, providing comprehensive support locally and through hands-on education and industry sponsorships, to help improve patient outcomes.

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Source:
Géraldine Varoqui
Boston Scientific