Subcutaneous Implantable Defibrillator

System Specifications:

The EMBLEM MRI S-ICD is the second device in the EMBLEM S-ICD family and builds on previous size, longevity and remote patient management enhancements. Like transvenous ICDs, the EMBLEM MRI S-ICD System utilizes a pulse generator capable of delivering life-saving therapy. Unlike traditional ICDs, the EMBLEM MRI S-ICD System leaves the heart and vasculature untouched, avoiding potential complications associated with transvenous leads. The EMBLEM MRI S-ICD has been tested and approved for use in the MR environment when the conditions of use are met. It contains a separate MRI mode with a timer that will automatically return the device to programmed settings. AF Monitor™ has also been added. This is a tool designed to assist in the detection of new onset, silent, or the progression of AF through R-R variability. The new SMART Pass filter is designed to reduce cardiac over-sensing and bench testing has demonstrated a > 40% reduction in inappropriate therapy.