GMDN Preferred Term Name GMDN Definition; Polymeric ureteral stent A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. • The safety of the Neuroform Microdelivery Stent System in patients below the age of 18 has not been established. Boston Scientific WallFlex® Enteral Stents Shown To Be Safe and Effective in Three Clinical Registries Studies published in peer-reviewed medical journals Boston Scientific Corporation (NYSE: BSX) welcomes positive results from three studies of the WallFlex® Enteral Stent … The NIR stent was developed and is manufactured by Medinol Ltd. of Tel Aviv, Israel. The Advanix Biliary Stent and NaviFlex RX Delivery System are available in a variety of options: RX pre-loaded systems, singles, multiple sizes and shapes to accommodate physician preferences, different disease states and patient anatomies. THE List. MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION Magnetic Resonance MR Conditional Non-clinical testing has demonstrated the VENOUS WALLSTENTsystem is MR Conditional for single and overlapping lengths up to 120 mm. Information applies to the following: CRT-P - Eluna 8 HF-T, Epyra 8 HF-T, Etrin. 9. Stent Implant Location Aortic Arch Right Coronary Artery (RCA) Left Anterior Descending Artery (LAD) Left Main (LM) Circumflex Artery REBEL™ Platinum Chromium Coronary Stent System Patient Information Guide Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537 1.888.272.1001 www.BostonScientific.com Boston Scientific to Release Long-Term Clinical Trial Results on Market-Leading TAXUS® Express 2 ™ Coronary Stent System at TCT 2005 (October 10, 2005) -- Boston Scientific Corporation (NYSE: BSX) today announced the schedule of the Company ProMRI Cardiac Resynchronization Systems (CRT), Cardiac Pacemaker Systems (Biotronik): Exclusion Zone MRI at 1.5-T/64-MHz. Pete Nicholas, Chairman and Chief Executive Officer of Boston Scientific, said, "The introduction of the NIR stent platform in the Safety Topic / Subject Fracture Fixation System Conventus Orthopaedics, Inc., www.conventusortho.com. $599.00 box of 1 - Boston Scientific # M00570370 - Boston Scientific WallFlex RX Fully Covered Biliary Stent: 10mm x 60mm A patient with this stent can be scanned safely, immediately … The XIENCE V® stent should not migrate in this MRI environment. Percuflex Plus Stent Graft with Suprarenal Ureteral Stent 4.8 Fr. Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating. The Express 2 Monorail and Over-the-Wire Coronary Stent Systems have not yet been marketed in any country. Boston Scientific ‘s EMBLEM subcutaneous implantable defibrillator (S-ICD) received European approval to be compatible with magnetic resonance imaging (MRI) when certain precautions are taken. The device doesn’t resort to having an electrode lead placed into the heart, but instead uses a long and thin rod near the chest to deliver the shock. MAGNETIC RESONANCE IMAGING (MRI) Non-clinical testing has demonstrated the EpicA Stent System is MR Conditional. Object Status. A patient with this device can be safely scanned in a Magnetic Resonance system meeting the following conditions: AccessGUDID - Ascerta™ Firm (08714729861768)- Ureteral Stent. In fact, the FDA has said it is okay to undergo MRI almost immediately after having received some of the most commonly used stents. The longer a stent is in place, the more cells from the artery's inner lining will have grown over and around the metal struts of the stent, like ivy on a trellis. Object Description. (April 5, 2005) -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved enhancements to the Directions for Use (DFU) of the TAXUS® Express 2 ™ paclitaxel-eluting coronary stent system, indicating that patients receiving the stent systems may safely undergo Magnetic Resonance Imaging (MRI) examination immediately following implantation. Object Description. These results represent the highest 12-month primary patency reported for an interventional treatment of … Conditional 6 More... Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices More... Niti-S Biliary Stent (LCD-type) TaeWoong Medical Co., Ltd., www.stent.net. MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION Non‐clinical testing has demonstrated that WALLSTENT TIPS is MR Conditional for single and overlapping lengths up to 94 mm. It can be scanned safely up to a total length of 155 mm and overlapping stents … (1.6 mm x 220 mm) Microvasive Boston Scientific Corporation Watertown, MA The Express Coronary Stent System was granted approval by Boston Scientific’s notified body (TUV Rheinland) to permit CE marking June 18, 2001. In Stock! The company recently initiated SPIRIT II AND SPIRIT III, large-scale pivotal clinical trials evaluating the safety and efficacy of Guidant''s drug eluting stent system for the treatment of coronary artery disease. BSC began marketing the product internationally following approval in September 2001. Boston Scientific Scimed has not marketed the Wallstent Venous Endoprosthesis for the central vein indication. MULTI-LINK DUET. MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the XIENCE V® stent. MR imaging within these conditions may be performed immediately following the implantation of the stent. MR Safe Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No Device labeled as "Not made with natural rubber latex": No For Single-Use: Yes … MRI Information. Stent. In Spin Echo and Gradient Echo sequence evaluations Neuroform stent image artifact extended approximately 2mm from the device. The results found that the stent was MRI safe with artifact affecting imaging at the location of the stent. Safety Topic / Subject. AccessGUDID - WallFlex™ Duodenal (08714729456483)- Stent System with Anchor Lock Delivery System Ships Today! 1.5,3. - Before every MRI, the device must be checked and correctly programmed. x 30 cm Length Magnetic Resonance Imaging (MRI) Safety Information: Non-clinical testing has demonstrated that the SYNERGY Stent is MR Conditional for single and overlapped conditions up to 75 mm. PR Newswire – MARLBOROUGH, Mass., Sept. 28, 2015 New 12-month clinical trial outcomes assessing the safety and performance of the Boston Scientific (NYSE: BSX) Eluvia™ Drug-Eluting Vascular Stent System reflect a primary patency rate 1 of more than 96 percent. Conditional 8 More... Coils, Filters, Stents… Access our instructions for use and product manuals library. While having an MRI with a stent is safe, it may not be safe to have a MRI with those devices. The surgeon who performed the surgery should have more information about what devices were implanted and whether an MRI is safe, and MRI technicians who have a patient’s complete medical file can usually make better judgments, too. 8. A patient with this device can be safely scanned in a Magnetic Resonance system meeting the following conditions: • Do not steam shape the tip of the 3F microdelivery catheter because it could damage the delivery system or stent. MRI Safety Information Non-clinical testing has demonstrated that the VICI VENOUS STENT® is MR Conditional. More recently, ex vivo study has been conducted on several of the more commonly used coronary drug-eluting stents, including 2005 to 2006 versions of the Cypher (Johnson & Johnson/Cordis), Taxus Express (Boston Scientific), Taxus Liberte (Boston Scientific), and Endeavor (Medtronic) stents. MRI Safety PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Below is an excerpt of Section 6.11 from the Directions for Use detailing the safety of performing MRI following the placement of a PROMUS Element Plus Stent. Ascerta Firm Disposable Ureteral Stent, 4.8 Fr dia. Magnetic Resonance Imaging (MRI) Safety Information: Non-clinical testing has demonstrated that the SYNERGY XD Stent is MR Conditional for single and overlapped conditions up to 94 mm. Boston Scientific has an exclusive worldwide license to market and distribute the NIR stent. Safety Topic / Subject VPASS Implant 316L SS Percardia Inc. Merrimack, NH. A patient with this stent can be scanned safely, immediately after placement, under the following conditions: MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the device. - The manufacturer’s warranty applies to the system composed of the device and lead (by the same manufacturer). The covered WallFlex™ Biliary RX Stent should not migrate in this Magnetic Resonance Imaging (MRI) environment, as magnetic force and torque in the non-clinical tests was less than the values exerted by the earth’s gravity. Object Status. Section 6.11 Magnetic Resonance Imaging (MRI) The Neuroform Stent should not migrate in this MRI environment. A chronology How unforeseen balloon failures forced Boston Scientific to recall a stent system eight weeks after it went on sale. Fully Automatic BiopsyGun MRI MRI Devices Corporation Waukesha, WI. MAGNETIC RESONANCE IMAGING (MRI) MRI Safety Information Magnetic Resonance Conditional • Non-clinical testing has demonstrated that the VICI VENOUS STENT System is Magnetic Resonance … 1.5: ... Fusion Zilver Biliary Stent System Cook Medical, www.cookmedical.com. For specific information about a Boston Scientific product's MR safety status, please refer to the product's Instructions For Use or contact Boston Scientific Customer Service. THE List. 1998 Aug. 11 FDA approves the sale of the NIR ON Ranger W/ SOX Stent System.. Aug. 12-19 Boston Scientific gets reports of 17 balloon failures from doctors and hospitals.. Aug. 25 The company starts an internal investigation.. Aug. 27 The company learns of … 3: Safe More... Miscellaneous Implants and Devices More... vProtect Luminal Shield Nitinol, Tantalum Stent ... stent Boston Scientific Natick, MA. MARLBOROUGH, Mass., March 22, 2016 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced the launch of the AXIOS ™ Stent and Electrocautery Enhanced Delivery System to help physicians manage two serious complications from pancreatitis using a minimally invasive endoscopic approach. Guidant plans to use its cobalt chromium stent technology in future drug eluting stent programs. What MRI safety information does the labeling contain? BOSTON SCIENTIFIC. 2.5 to 4.0-mm (RX and OTW) 316L SS. A patient with the VICI VENOUS STENT can be scanned safely, immediately after placement, in an MR system meeting the following conditions: • Static magnetic field of 1.5 T … For Healthcare Professionals. • After deployment, the stent may foreshorten up to 1.8% in 2.5 mm stents and up to 5.4% in 4.5 mm stents. Safety Topic / Subject. Safety Topic / Subject POLARIS Adjustable Pressure Valve Sophysa ... Cerebrospinal Fluid (CSF) Shunt Valves and Accessories More... Polaris Loop Ureteral Stent Boston Scientific Corporation www.bostonscientific.com. ACS/Guidant.
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