Boston Sci’s EMBLEM Subcutaneous Defibrillator Approved in EU for MRI Scans

Boston Scientific‘s EMBLEM subcutaneous implantable defibrillator (S-ICD) received European approval to be compatible with magnetic resonance imaging (MRI) when certain precautions are taken. The device doesn’t resort to having an electrode lead placed into the heart, but instead uses a long and thin rod near the chest to deliver the shock.

The approval applies to new EMBLEM devices as well as those already implanted in patients before the ruling. It is also limited to MRI scanners with magnetic fields up to 1.5 Tesla in strength.

The EMBLEM is intended to minimize side effects associated with traditional cardiac leads while offering comparable therapy to correct sudden cardiac arrests.

Some more from the announcement:

The EMBLEM MRI S-ICD System also includes two new features, SMART Pass technology and Atrial Fibrillation (AF) Monitor™. The SMART Pass technology will help ensure patients receive therapy from the device only when necessary by enhancing the INSIGHT™ Algorithm, which identifies and classifies a heart rhythm for effective arrhythmia treatment. This novel feature will also be added to previously implanted EMBLEM S-ICD Systems through a software update. The AF Monitor feature of the EMBLEM MRI S-ICD System is a new detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.