Magnetic Resonance (MR) Safety – HAART Aortic Annuloplasty Devices

MR Conditional

Non-clinical testing has demonstrated that the HAART 200 / 300 Aortic Annuloplasty Device is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

  • Static magnetic field of 1.5 T and 3 T
  • Maximum spatial field gradient of 4,000 G/cm (40 T/m)
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4.0 W/kg (First Level Controlled Operating Mode) at 3 T

RF Heating

Under the scan conditions defined above, the HAART 200 / 300 Aortic Annuloplasty Device is expected to produce a maximum temperature rise of less than 3.0°C after 15 minutes of continuous scanning.

Caution: The RF heating behavior does not scale with static field strength. Devices that do not exhibit detectable heating at one field strength may exhibit high values of localized heating at another field strength.

 

MR Artifact

In non-clinical testing, the image artifact caused by the device extends approximately 10 mm from the HAART 200 / 300 Aortic Annuloplasty Device when imaged with a gradient echo pulse sequence and a 3 T MRI system.

For full safety information view the Instructions for Use

View Instructions for Use