US-based medical device firm Boston Scientific has secured CE Mark in Europe for its new 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 EMBLEM S-ICD Systems serve as treatment options for patients vulnerable to sudden cardiac arrest (SCA), which leaves the heart and vasculature untouched, decreasing the risk of complications associated with transvenous implantable cardioverter-defibrillators (TV-ICDs).
Initial market release of the new EMBLEM MRI S-ICD System has commenced in a small number of centres in Europe. A Europe-wide launch is slated for this year.
The system features two new aspects, the SMART Pass technology and Atrial Fibrillation (AF) Monitor.
The SMART Pass technology will help ensure patients receive therapy from the device when necessary by improving the INSIGHT Algorithm.
The INSIGHT Algorithm identifies and categorises a heart rhythm for effective arrhythmia treatment. This feature can be incorporated into the previously implanted EMBLEM S-ICD Systems through a software update.
The AF monitor of the EMBLEM MRI S-ICD System is a new detection tool developed to notify physicians after identifying AF to facilitate a more informed treatment decision for their patients.
Boston Scientific rhythm management chief medical officer 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.
"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."
The EMBLEM S-ICD System will join the existing ImageReady MR-conditional devices in Europe which has been declared safe for use in a magnetic resonance image setting.
Patients receiving the EMBLEM MRI S-ICD System, and patients who were previously implanted with an EMBLEM S-ICD System can undergo full-body MR scans safely in 1.5 Tesla environments when conditions of use are met.
Boston Scientific is currently seeking US Food and Drug Administration (FDA) approval of the EMBLEM MRI S-ICD System, as well as MR-conditional labeling for previously implanted EMBLEM S-ICD Systems.
The global ENABLE MRI study, initiated earlier this year, is intended to support FDA approval for MR-conditional labeling across the company’s currently approved ICD and cardiac resynchronisation therapy systems.
Image: An image of the EMBLEM MRI S-ICD System. Photo: courtesy of Boston Scientific Corporation