Edwards Lifesciences - Carpentier-Edwards BioPhysio valve

MRI Safety information for:

Carpentier-Edwards BioPhysio valve

Conditional

Edwards Lifesciences

valve

(Exclusively for Clinical Investigations / Investigational Device / To Be Used by Qualified Investigators only)

The device has been shown not to have magnetic interactions at up to 3 tesla. It is also safe with respect to RF heating at 1.5 W/kg for up to 20 minutes. Artifacts have been determined at 1.5 tesla. Optimization of MR imaging parameters is recommended.