AAA-SHAPE Pivotal Trial
MRI and Safety Information
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.