Boston Scientific (NYSE:BSX) said today that the FDA approved its Emblem MRI subcutaneous implantable defibrillator system and magnetic resonance conditional labeling for all previously implanted Emblem S-ICD systems.
The Marlborough, Mass.-based company’s Emblem S-ICD systems are designed to treat patients at risk of sudden cardiac arrest without the risk of complications associated with transvenous implantable cardioverter-defibrillators.
Patients equipped with the Emblem devices are now cleared for full-body MRI scans in 1.5 tesla environments when conditions of use are met, Boston Scientific said.
“Now with FDA approval, patients receiving the Emblem MRI 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,” rhythm management chief medical officer Dr. Kenneth Stein said in prepared remarks.
Boston Scientific said it began commercializing the Emblem MRI device in Europe in June, after winning CE Mark approval there in April.
In June 2015, Boston Scientific launched a global clinical trial for the flagship Emblem S-ICD in primary prevention patients with severely reduced cardiac function.
The Untouched study is slated to enroll a minimum of 2,015 patients with no documented, life-threatening arrhythmic event who are at risk of sudden cardiac death. The 18-month study will compare outcomes with the performance markers set out in the Madit-RIT trial of transvenous ICDs, Boston Scientific said at the time.
