Nexus Embolization Coil Nexus X-10-20-T10-TC Platinum-Iridium, Nitinol Micro Therapeutics, Inc. Irvine, CA accordance with 21 CFR 801.109 W. L. Gore & Associates, Inc. Migration Summary for GORE VIABIL Biliary Endoprosthesis and Boston Scientific WALLFLEX Biliary RX Fully Covered Stent. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV for use in the vascular system has not been established. Boston Scientific has initiated the US and international launch of its WallFlex biliary transhepatic stent system, along with a percutaneous delivery system, designed for use by interventional radiologists in the palliative treatment of biliary strictures produced by malignant tumours. WARNING: The safety and effectiveness of the WallFlex Biliary Stent for use in the vascular system has not been established. AccessGUDID - WallFlex Biliary Transhepatic (08714729820512)- Stent System. GMDN Preferred Term Name GMDN Definition; Polymer-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile The safety and effectiveness of the WallFlex Biliary RX Stent System for use in the vascular system have not been established. *** A stent cannot be reconstrained after the reconstrainment line has been exceeded 23.2, B) are available in pcSEMS variants. LIMITATIONS The WallFlex Biliary RX Fully covered Stent is designed to meet these needs. On (b)(6) 2016, an assessment of biliary obstructive symptoms was taken and reported fever/chills and jaundice. Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. Closed cell construction and Permalume covered options designed to help resist tissue in-growth.1,2. The RX biliary delivery system is reconstrainable up to 80% of deployment to aid in repositioning*** and is designed to facilitate physician control. WallFlex Biliary Transhepatic Stent System. 23.2, C), Viabil stent (W.L. Boston Scientific Corporation has welcomed positive results from three studies of the WallFlex Enteral Stent Systems, a family of self-expanding metal stents (SEMS) used to alleviate obstructive symptoms caused by cancers of the gastrointestinal tract. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Cochrane Database Systematic Review, 25 Jan. 2006. The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity. PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. Boston Scientific Corporation (NYSE: BSX) today announced the European availability of the WallFlex(R) Biliary RX Stent for the palliative treatment of malignant common bile duct strictures. The Program is subject to modification or termination by Boston Scientific without prior notification. 9. GMDN Preferred Term Name GMDN Definition; Polymer-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Biliary sphincterotomy, if not done previously, was performed. (MRI) Safety for Boston Scientific Peripheral Products PDF, 272.0 KB. GMDN Preferred Term Name GMDN Definition; Bare-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Take action in addressing health inequities in your community. In addition, the WallFlex Biliary RX Fully Covered stent is CE marked for the treatment of benign biliary strictures. Below please find ordering information for WallFlex Biliary RX Stents. Placement in strictures that cannot be dilated enough to pass the delivery system. Top. Radial force helps maintain stent patency and resist migration. This study was undertaken to evaluate the safety and clinical effectiveness of this new stent for palliative treatment in patients with inoperable extrahepatic malignant biliary obstruction. Helping you deliver the best patient care possible. Model #: 7089 Wallflex Biliary Stent system RX UNCOVERED - 10mm x 40mm. EDUCARE makes it simple. Replacement stents provided under the Program are not eligible for the Program. Boston Scientific Corporation announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its WallFlex() Biliary RX fully and partially covered stents for the palliative treatment of malignant bile duct strictures. NOTe: Use of the WallFlex Biliary RX Fully Covered Stent for the treatment of benign strictures or stenoses has not been cleared for use in the United States. The first publication appeared in the October 2011 issue of Gastrointestinal Endoscopy, and reported the short-term safety and effectiveness of the Boston Scientific WallFlex enteral colonic stent for relieving malignant colorectal obstruction. Safety Topic / Subject Cortical bone screw small (titanium alloy) orthopedic implant Boston Scientific, www.bostonscientific.com. In the United States, the WallFlex Biliary RX Fully Covered Stent System RMV is cleared for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. Boston Scientific 3422 Advanix Biliary Stent w Naviflex RX Delivery System is designed to maximize flow rates, improve pushability through tortuous anatomy, and be repositionable to aid in accurate placement. The FDA said today it is reclassifying Boston Scientifics (NYSE:BSX) WallFlex Biliary RX fully covered stent system to a Class II device.. One schedule - yours. Polymer-metal biliary stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. Boston Scientific. It was reported to boston scientific corporation that a wallflex biliary rx covered stent was to be implanted to treat a stenosis in the common bile duct during a stenting procedure performed on (b)(6) 2020. ** In the event of incorrect positioning during the initial stent placement procedure, the partially covered and fully covered stent options may be removed using forceps to grasp the retrieval loop on the end of the stent. Warnings: The safety and effectiveness of the stent has not been established for indwell periods exceeding 12 months. Top. The results found that the stent was MRI safe with artifact affecting imaging at the location of the stent. Migration Resistance 1 The safety and effectiveness of the WallFlex Biliary RX Stenting System for use in the vascular system have not been established. Safety Topic / Subject Ultraflex Tracheobronchial Stent Boston Scientific, www.bostonscientific.com. Reconstrainable delivery system (up to 80%) facilitates physician control and locking of guidewire, Looped and flared stent ends designed to reduce the risk of tissue trauma and stent migration, Platinol Wire construction provides flexibility to aid placement in tortuous anatomies. The WallFlex Biliary RX Fully Covered Stent System RMV should not be used in patients for whom endoscopic techniques are contraindicated. WallFlex Enteral Colonic Stent with Anchor Lock Delivery System Nitinol stent Boston Scientific Natick, MA Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The safety and effectiveness of the WallFlex Biliary RX Fully Covered Stent System RMV has not been established in the treatment of benign biliary anastomotic strictures in liver transplant patients and benign biliary post abdominal surgery strictures. Indications, Safety and Warnings; Stents: Gastrointestinal . Warning: No warranty is made with regard to removability of this device by endoscopic means or otherwise. AccessGUDID - WallFlex Biliary (08714729953173)- Stent System RMV. The WallFlex Biliary RX Fully Covered Stent System RMV is currently the only biliary metal stent in the U.S. for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis. Contraindications: Boston Scientific's (BSX) WallFlex Biliary RX Stent has received CE Mark in Europe for curing biliary strictures produced by malignant neoplasms as well as for benign biliary strictures therapy The WallFlex Biliary Stents are CE Marked for use in the palliative treatment of biliary strictures produced by malignant neoplasms and for treatment of benign biliary strictures. The safety and effectiveness of the WallFlex Biliary RX Stent System for use in the vascular system have not been established. Two decades of metal stent development and demonstrated safety and effectiveness from multiple studies have helped make WallFlex Biliary Stents the most frequently implanted biliary metal stent throughout the U.S., Canada, and Europe. The WallFlex Biliary RX Fully Covered Stent should not be placed in strictures that cannot be dilated enough to pass the delivery system, in a perforated duct, or in very small intrahepatic ducts. October 6, 2009 - Boston Scientific Corp. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its WallFlex Biliary RX fully and partially covered stents for the palliative treatment of malignant bile duct strictures. The sale, distribution, and use of the device are restricted to prescription use in Note the acute angle of delivery in fluoro image #4. Uncovered WallFlex Biliary RX Stent System Boston Scientific Corporation Marlborough, MA. MR imaging within these conditions may be performed immediately following the implantation of the stent. **** Endoscopic and fluoroscopic images courtesy of Adrian Hatfield, MD and Thomas Kowalski, MD. Stents provided pursuant to the Program will be accompanied by a no-charge invoice shipped directly to the hospital upon receipt of the appropriate documentation. The WallFlex Biliary RX Uncovered Stent System is contraindicated for: Placement in biliary strictures caused by benign tumors, as the longterm effects of the stent in the bile duct is unknown. The WallFlex Biliary RX Stent is 510(k) cleared for the treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. NATICK, Massachusetts, October 22, 2010 /PRNewswire/ -- Boston Scientific Corporation today announced that its WallFlex(R) Biliary RX Fully Covered Stent has received CE Mark approval for the treatment of benign biliary strictures. Fully covered stent is designed for removal up to 12 months post-placement. All rights reserved. Boston Scientific Corporation has announced that the first patient has been enrolled in a clinical trial to evaluate its WallFlex biliary RX fully covered stent for the treatment of benign bile duct strictures. For products available in other countries, please choose one of our other websites from the region selector at the top of the site or contact your local Cook Medical representative. For an expanded indication to treat benign Biliary strictures System RMV is for single-use only ( WallFlex RX, C ), Viabil Stent ( s ) are available in variants Not mean it has been evaluated by the U.S. Federal Government Stent Scientific! Prior plastic Biliary Stent System RMV is for single-use only deployed using endoscopic Visualization prior WallFlex Covered. Peripheral Products PDF, 272.0 KB an assessment of Biliary obstructive symptoms was taken and fever/chills! 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