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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CAUTION: USA: Investigational device. Limited by Federal (or United States) law to investigational use.

Canada: Investigational device. To be used by qualified investigators only.

Cardiac Dimensions, Carillon, Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions Pty Ltd.

The Carillon Mitral Contour System is CE Marked (0344) and is commercially available in Europe and other countries.