These coronary artery stents include the following: In February, Boston Scientific Corporation received CE Mark approval for the Eluvia drug-eluting vascular stent system, a self-expanding nitinol DES designed for the treatment of lesions in the femoropopliteal arteries (Figure1). A stent crimping technology, which provides excellent stent retention and provides smooth surface transition across the stent and delivery system. Eluvia is the only DES for the SFA that utilizes the well-known antirestenotic drug paclitaxel in conjunction REFERENCE STATEMENT. Boston Scientific, www.bostonscientific.com . Guidant studied the MULTI-LINK TETRA''s safety and effectiveness by conducting the MULTI-LINK TETRA registry with 202 patients at more than 16 sites throughout the U.S. and Europe. Boston Scientific announced the FDA's decision in a press release April 5, 2005. Indications: The Visi-Pro™ balloon-expandable peripheral stent system is indicated for improving luminal diameter in patients with atherosclerotic disease of the common and/or external iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 10 mm. Guidant studied the MULTI-LINK TETRA''s safety and effectiveness by conducting the MULTI-LINK TETRA registry with 202 patients at more than 16 sites throughout the U.S. and Europe. We'd strongly suggest calling Boston Scientific Patient Services at 1.866.484.3268 for specific assistance on this issue. • When crossing a newly deployed stent with a coronary guide wire, balloon or delivery system, exercise care to avoid disrupting the stent geometry. Recently, MR safety information has been obtained for several bare wire and drug-eluting coronary stents, which have been reported to be safe for patients undergoing MR procedures at 3T or less (based on assessments of magnetic field interactions and MRI-related heating). Evaluate the safety and effectiveness of the Promus PtCr EES Coronary Stent System* for the treatment of patients with up to 2 de novo lesions ≤ 24 mm in length; ≥ 2.50 mm to ≤ 4.25 mm in diameter compared to the Xience CoCr EES. The Eluvia Stent uses the same fluoropolymer as the PROMUS™ and XIENCE™ coronary stents which have a proven history of safety in the body. MRI Safety and Stents Tweet. The results found that the stent was MRI safe with artifact affecting imaging at the location of the stent. For Healthcare Professionals 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 only information on the stent that we have it that it was manufactured by Boston Scientific and it is either a "one star" or "three star". MRI … These coronary artery stents include the following: Recently, MR safety information has been obtained for several bare wire and drug-eluting coronary stents, which have been reported to be safe for patients undergoing MR procedures at 3T or less (based on assessments of magnetic field interactions and MRI-related heating). The safety of MRI within 24 hours of stent implantation has not been formally studied. REBEL™ Platinum Chromium Coronary Stent System is a product of Boston Scientific Corporation. The Eluvia Stent uses the same fluoropolymer as the PROMUS™ and XIENCE™ coronary stents which have a proven history of safety in the body. Also definitely tell the technicians doing the MRI about the stent -- they can adjust the Tesla strength for safety. 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. 9. MRI safety testing has shown that the REBEL™ Stent is MR Conditional and that These results represent the highest 12-month primary patency reported for an interventional treatment of … Access our instructions for use and product manuals library. More than 20 million implants 1 ; More than 100,000 patients studied 2; Data on file at Boston Scientific. A stent crimping technology, which provides excellent stent retention and provides smooth surface transition across the stent and delivery system. Boston Scientific Scimed has not marketed the Wallstent Venous Endoprosthesis for the central vein indication. x The Guidant MULTI-LINK PENTA Coronary Stent has been shown in non-clinical testing to be MRI safe immediately following implantation. Section 6.11 Magnetic Resonance Imaging (MRI) The new DFU make the Taxus stent the first drug-eluting stent to receive approval for immediate postprocedure MRI. To investigate the long‐term safety of cardiac magnetic resonance imaging (CMR) performed one to seven days after coronary artery stent (bare metal) implantation. 1.5, 3: Conditional 5 More... Coils, Filters, Stents, and Grafts More... 3/4" Socket Wrench ... 880 MRI Compatible Anaesthesia Machine Mechanical ventilation Pneupac