REBEL Coronary Stents
Non-clinical testing has demonstrated that the REBEL Stent is MR Conditional for single and overlappedconditions up to 74 mm. A patient with this device can be safely scanned in a Magnetic Resonance systemmeeting the following conditions:
• Static magnetic field of 3.0 and 1.5 Tesla only
• Maximum spatial gradient magnetic field of 2200 gauss/cm (22 T/m)
• Maximum Magnetic Resonance system reported, whole body averaged specific absorption rate (SAR)of <2 W/kg (Normal Operating Mode).
Under the scan conditions defined above, the REBEL Stent is expected to produce a maximum temperature rise of 2.6ºC after 15 minutes of continuous scanning.
The stent(s) should not migrate in this MRI environment and MRI may be performed immediately following the implantation of a REBEL Stent(s). Prior to undergoing an MRI scan, inform your doctor that you have a REBEL Stent. MR image quality will be compromised if the area of interest is in the same area or relatively close to the position of the stent.