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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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.

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.