Subcutaneous ICD Protects the Beating Heart

A novel implantable cardioverter defibrillator (ICD) uses a subcutaneous electrode to analyze heart rhythm, in order to effectively protect patients from sudden cardiac arrest (SCA), while leaving the heart and vasculature untouched.

The EMBLEM S-ICD System provides a new solution to protect patients from SCA without touching the heart, avoiding potential complications associated with transvenous implantable defibrillators. While the EMBLEM S-ICD System utilizes a pulse generator--similar to those in a transvenous ICD--it differs in that it uses a subcutaneous electrode to analyze the heart rhythm, rather than individual beats to effectively sense, discriminate, and convert ventricular fibrillation (VF) and ventricular tachycardia (VT).

The EMBLEM S-ICD System also includes SMART Pass technology, which helps ensure patients receive therapy from the device only when necessary by enhancing a proprietary algorithm that identifies and classifies heart rhythm for effective arrhythmia treatment. A second feature, the atrial fibrillation (AF) monitor, is designed to help physicians make more informed treatment decisions. The EMBLEM S-ICD family is a product of Boston Scientific Corporation (Natick, MA, USA), and has received the European Community CE mark of approval.

In Europe, the EMBLEM magnetic resonance imaging (MRI) S-ICD System has been designated as an Image Ready MR-conditional device, and is labeled safe for use in a MRI setting. Patients receiving the EMBLEM MRI S-ICD System, as well as patients who previously were implanted with an EMBLEM S-ICD system are now able to undergo full-body MR scans safely in 1.5 Tesla environments, when conditions of use are met. Boston Scientific is actively pursuing U.S. Food and Drug Administration (FDA) approval of the systems.

“These approvals give reassurance to physicians and their patients that they have access to any future MR scan needs, and underscores the Boston Scientific commitment to gain MR-conditional labeling on high-voltage devices that are being implanted today,” said Kenneth Stein, MD, chief medical officer of rhythm management at Boston Scientific. “Further, the EMBLEM S-ICD System is a compelling treatment option for the majority of ICD-indicated patients that provides protection from cardiac arrest without invading the heart and blood vessels.”

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