Prestyled Freestyle™ Modified Subcoronary Bioprosthesis

MEDTRONIC, INC.

Aortic heart valve bioprosthesis

The Freestyle subcoronary bioprosthesis, Model 995MS, is magnetic resonance (MR) safe. The bioprosthesis contains no metal and, therefore, poses no known hazards in all MR environments. The device will not cause any harm to the patient when exposed to MR scanning immediately after implantation. MRI at 3.0 T and 1.5 T may be performed immediately following implantation of the device.

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. It may be necessary to optimize MR imaging parameters for the presence of this implant.