LVIS™ EVO™ Indications, Safety, and Warnings

MRI Safety Information

United States

The LVIS (Low-profile Visualized Intraluminal Support) device is MR Conditional. A patient with the LVIS (Low-profile Visualized Intraluminal Support) device may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient. 

• Nominal Values of Static Magnetic Field (T) – 1.5-Tesla or 3-Tesla, only 

• Maximum Spatial Field Gradient (T/m and gauss/cm) – 4,000-gauss/cm (40-T/m) 

• Type of RF Excitation – Circularly Polarized (CP) (i.e., quadrature-driven) 

• Transmit RF Coil Information – There are no transmit RF coil restrictions. Accordingly, the following may be used: body transmit RF coil and all other RF coil combinations (i.e., body RF coil combined with any receive-only RF coil, transmit/receive head RF coil, transmit/receive knee RF coil, etc.) 

• Operating Mode of MR System – Normal Operating Mode

• Maximum Whole Body Averaged SAR – 2-W/kg (Normal Operating Mode

• Maximum Head SAR – 3.2-W/kg (Normal Operating Mode)

• Limits on Scan Duration – Whole body averaged SAR of 2-W.kg for 60 minutes of continuous RF exposure (i.e., per pulse sequence or back to back sequences/ series without breaks)

• MR Image Artifact – The presence of this implant produces an imaging artifact. Therefore, carefully select pulse sequence parameters if the implant is located in the area of interest. 

EU & CHAPLA

Non-clinical testing demonstrated that the LVIS EVO device is MR Conditional. A patient with an implant from this family can be scanned safely in an MR system under the following conditions. Failure to follow these conditions may result in injury to the patient. 

• Static magnetic field of 1.5-Tesla or 3-Tesla, only 

• Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m) 

• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode 

Under the scan conditions defined, an implant from the LVIS EVO Stent is expected to produce a maximum temperature rise of 3.8°C after 15-minutes of continuous scanning (i.e., per pulse sequence). In non-clinical testing, the image artifact caused by an implant from the LVIS EVO Stent extends approximately 4 mm from this implant when imaged using a gradient echo pulse sequence and a 3-Tesla MR system. The lumen of the LVIS EVO Stent could not be visualized on gradient echo or T1-weighted, spin echo pulse sequences.