Ellipse Implantable Cardioverter Defibrillator (ICD)

Abbott Vascular

Implantable Cardioverter Defibrillator

Abbott conducted extensive testing using industry-standard methods to demonstrate the safety of the Ellipse ICD system with Durata/Optisure /Tendril MRI leads for conditional Magnetic Resonance Imaging. This included but was not limited to comprehensive computer modeling across a broad range of clinical scenarios. The performance of the Ellipse ICD and Durata/Optisure leads was also evaluated in an Investigational Device Study (IDE). Ellipse ICD is conditionally safe for use in the MRI environment when used with Durata/Optisure/ Tendril MRI leads, and according to the instructions in the Abbott MRI Ready Systems Manual. For additional information about specific MR Conditional ICD and lead model numbers, including warnings, precautions, adverse conditions to MRI scanning, and potential adverse events please refer to the Abbott MRI Ready Systems Manual at manuals.sjm.com/ or check our MRI Ready resources at sjm.com/mriready. Please contact your local Abbott Sales Representative with any additional questions.