Medical devices manufacturer Boston Scientific has received CE mark approval for third-generation Emblem subcutaneous implantable defibrillator (S-ICD) system.
The company has also obtained approval for magnetic resonance (MR) conditional labeling for all previously implanted Emblem S-ICD systems.
Emblem S-ICD systems were developed to treat patients at risk of sudden cardiac arrest (SCA) that leave the heart and vasculature unmoved, as well as to reduce the risk of complications associated with transvenous implantable cardioverter-defibrillators (TV-ICDs).
The new system comprise of two new features such as Smart Pass technology and atrial fibrillation (AF) monitor.
Smart Pass technology will enable patients to receive therapy from the device only when necessary by enhancing the Insight algorithm that identifies and classifies a heart rhythm for effective arrhythmia treatment.
The AF monitor is a new detection tool that alerts physicians after the identification of AF, helping in providing informed treatment decisions for their patients.
According to the company, patients receiving Emblem MRI S-ICD system and patients who previously were implanted with an Emblem S-ICD system can now undergo full-body MR scans in 1.5 Tesla environments when conditions of use are met.
Boston Scientific rhythm management chief medical officer Dr Kenneth Stein said: "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."
The company, which provided the device to the limited number of European centers, is planning a broad launch in early summer.
In addition, the firm is pursuing the US Food and Drug Administration (FDA) approval of the Emblem MRI S-ICD System and MR-conditional labeling for previously implanted Emblem S-ICD systems.
Image: Boston Scientific’s corporate headquarters in Marlborough, Massachusetts. Photo: courtesy of Boston Scientific Corporation.