AAA-SHAPE Pivotal Trial
MRI, Safety Information, and Instructions for Use
Caution – INVESTIGATIONAL DEVICE, LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.
Intended Use and Indication for Use: The IMPEDE-FX RapidFill Device is intended to be used with commercially available endovascular grafts in the treatment of patients meeting the minimum anatomical criteria, with infrarenal abdominal aortic aneurysms (AAAs). Once the endovascular aneurysm repair (EVAR) procedure is complete, the IMPEDE-FX RapidFill Device is used to fill the aneurysm sac with IMPEDE-FX RapidFill implants to promote aneurysm shrinkage.
MRI & Safety Information
Non-clinical testing and MRI simulations demonstrated that the IMPEDE-FX RapidFill is MR Conditional. Refer to Table 1 for the MRI Safety Information.
Table 1: IMPEDE-FX RapidFill MRI Safety Information
|MRI Safety Information
Non-clinical testing and MRI simulations were performed to evaluate the IMPEDE-FX RapidFill device. These results demonstrate that the IMPEDE-FX RapidFill device is MR Conditional. A patient with the IMPEDE-FX RapidFill device may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient. If information about a specific parameter is not included, there are no conditions associated with that parameter.
|Parameter||Condition of Use/Information|
|Nominal Values of Static Magnetic Field (T)||1.5-Tesla or 3.0-Tesla|
|Maximum Spatial Field Gradient
(T/m and gauss/cm)
|Type of RF Excitation||Circularly Polarized (CP) (i.e., Quadrature-Transmission)|
|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)|
|Limits on Scan Duration||Whole body averaged SAR of 2-W/kg for 15 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.|
Investigational Device: IMPEDE-FX RapidFill
Click below to download the Instructions for Use