Magnetic Resonance Imaging (MRI) Safety Information

Non-clinical testing demonstrated that the Contour and Neqstent implants are MR Conditional. A patient with this device can be scanned safely in an MR system immediately after placement under the following conditions:

• Static magnetic field of 1.5 Tesla and 3 Tesla, only

• Maximum spatial gradient magnetic field of 2,000-gauss/cm (20 Tesla/m) (extrapolated) or less

• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the First Level Controlled Operating Mode of operation for the MR system.

Under the scan conditions defined above, the implant is expected to produce a maximum temperature rise of 2.3°C after 15 minutes of continuous scanning (i.e., per pulse sequence).

In non-clinical testing, the image artifact caused by the implant extends approximately 10 mm from the implant when imaged using a gradient echo pulse sequence and a 3 Tesla MR system.

 

 

 

 

Caution:  Products are not available for sale in the United States.