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MRI Compatibility

Carillon Mitral Contour System®

Magnetic Resonance Imaging (MRI) Compatibility: MR Conditional

Non-clinical testing has demonstrated the Carillon Mitral Contour System implant is MR Conditional. It can be safely scanned under the following conditions:

  • Static magnetic field of 3 T or 1.5 T
  • Maximum spatial gradient field of 1900 gauss/cm (19 T/m)
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of ≤ 2 W/kg (Normal Operating Mode)

Under the scan conditions defined above, non-clinical testing results (including the effect of blood perfusion) indicate the Carillon Mitral Contour System is expected to produce a maximum temperature rise of less than 3.2°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 20 mm from the Carillon Mitral Contour System when imaged with a gradient echo pulse sequence and a 3 T MR system.

Pulse Sequence T1-SE T1-SE GRE GRE
Signal Void Size 1,951 mm2 384 mm2 2,279 mm2 644 mm2
Plane Orientation Parallel Perpendicular Parallel Perpendicular
Pulse Sequence Signal Void Size Plane Orientation
T1-SE 1,951 mm2 Parallel
T1-SE 384 mm2 Perpendicular
GRE 2,279 mm2 Parallel
GRE 644 mm2 Perpendicular

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    © 2023 Cardiac Dimensions. All rights reserved.

    *NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.

    CAUTION: Investigational Device. Limited by United States law to investigational use.

    Cardiac Dimensions logo - horizontal

    © 2022 Cardiac Dimensions. All rights reserved.

    *NOTE: The Carillon Mitral Contour System has received CE Mark (0344) and is available for sale in Europe and other countries that recognize CE Mark.

    CAUTION: Investigational Device. Limited by United States law to investigational use.