US FDA approves Boston Scientific Emblem MRI S-ICD system

Boston Scientific Emblem

Boston Scientific has received US Food and Drug Administration (FDA) approval for the Emblem MRI subcutaneous implantable defibrillator (S-ICD) system, as well as magnetic resonance (MR) conditional labelling for all previously implanted EMBLEM S-ICD systems.

The new Emblem MRI S-ICD system is the latest addition to the company’s growing line of ImageReady MR-conditional devices, which are designed to allow patients to undergo magnetic resonance imaging (MRI) safely.

Boston Scientific received CE mark for the Emblem MRI S-ICD system earlier this year, and began commercialisation in Europe in June 2016. In addition to MR-conditional labelling, the device introduces two new features to the market; Smart Pass technology and an atrial fibrillation monitor. The Smart Pass technology, also being added to previously implanted Emblem S-ICD systems through a software update, is designed to increase the accuracy of the Insight algorithm, to help ensure patients receive appropriate therapy from the device only when necessary. The monitor feature is a detection tool designed to alert physicians after the identification of atrial fibrillation so they can make more informed treatment decisions for their patients.