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MRI Compatibility

Carillon Mitral Contour System® European Magnetic Resonance Imaging (MRI) Compatibility: MR Conditional

Non-clinical testing has demonstrated the Carillon Device is MR Conditional according to the terminology specified in the ASTM International Standard F2503. It can be safely scanned under the following conditions:

  • Static magnetic field of 3.0 Tesla
  • Spatial gradient field of 720 Gauss/cm
  • Maximum whole body averaged specific absorption rate (SAR) of 2.9 W/kg for 15 minutes of scanning

In non-clinical testing, the Carillon Device produced a temperature rise of less than or equal to 2.3°C at a maximum whole-body SAR of 2.9 W/kg, as assessed by calorimetry for 15 minutes of MR scanning in a 3.0 Tesla (3.0 Tesla/128 MHz, Excite, HDX, Software 14x.M5, General Electric Healthcare, Milwaukee, WI) MR system.

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Carillon Device. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. Artifacts were in the form of signal voids as follows:

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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    Cardiac Dimensions logo - horizontal

    © 2021 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

    © 2021 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.