MRI Safety information for:
Edwards SAPIEN 3 Ultra transcatheter heart valve (THV) (US CONDITIONALS)
Edwards Lifesciences
Aortic transcatheter heart valve bioprosthesis, stent-like framework, Mitral transcatheter heart valve bioprosthesis
Non-clinical testing has demonstrated that the Edwards SAPIEN 3 transcatheter heart valve and the Edwards SAPIEN 3 Ultra transcatheter heart valve are MR Conditional. A patient with this device can be scanned safely, immediately after placement of this device under the following conditions. (US CONDITIONALS)