The approval grants magnetic resonance (MR) conditional labeling to all Emblem S-ICD systems, expanding the company's ImageReady portfolio.
The Emblem S-ICD system offers a treatment option for patients at risk of sudden cardiac arrest, which leave the heart and vasculature unmoved.
It will also reduce the risk of complications associated with conventional transvenous implantable cardioverter-defibrillator leads.
Boston Scientific rhythm management chief medical officer Kenneth Stein said: "Now with FDA approval, patients receiving the Emblem S-ICD system, as well as patients who previously were implanted with an Emblem S-ICD system, have reassurance they can safely undergo MR scans while remaining protected from cardiac arrest.”
In April, the company received CE mark approval for the Emblem S-ICD system to market in the Europe.
The system includes two new features, including Smart Pass technology and atrial fibrillation (AF) monitor.
Smart Pass technology will enable patients to receive appropriate therapy from the device only when necessary by increasing the accuracy of the Insight algorithm.
The AF Monitor is a new detection tool that will alert physicians after the identification of AF, helping to take informed treatment decisions for their patients
Earlier this year, the firm secured FDA approval for the ImageReady MR-conditional pacing system.
The system includes Accolade MRI and Essentio MRI pacemakers, as well as Ingevity MRI pacing leads for the treatment of bradycardia.
Image: Boston Scientific's corporate headquarters in Marlborough, Massachusetts. Photo: courtesy of Boston Scientific Corporation.
