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Dear Imaging Center - .NET Framework

PP--US-0878 Page 1 of 25 Dear Imaging Center : This letter is in response to your inquiry concerning the safety of performing magnetic resonance (MR) procedures in patients who have been implanted with Edwards Lifesciences LLC (formerly Baxter Healthcare Corporation, CardioVascular Group) heart valve therapy products. MR Information: MR procedures have been performed on numerous occasions on patients with Edwards implantable products without reported problems. The products listed below are made from non-ferromagnetic, weakly ferromagnetic materials or paramagnetic materials. For all products, the in vivo forces are greater than those pertaining to the magnetic field interactions ( , the forces associated with translational attraction and torque are less than those associated with gravitational forces).

these conditions. MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of these devices. Optimization of MR imaging parameters is recommended. The valve wireform stent is composed of a corrosion-resistant cobalt-chromium spring alloy that is commonly used in implantable devices.

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