Boston Scientific wins CE Mark for MR-safe Emblem S-ICDs

Boston Scientific (NYSE:BSX) said today it won CE Mark approval for 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 patietns at risk of sudden cardiac arrest without the risk of complications associated with transvenous implantable cardioverter-defibrillators.

“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,” rhythm management chief medical officer Dr. Kenneth Stein said in a press release.

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.

The company said it is “actively pursuing” FDA approval of the Emblem MRI S-ICD system as well as MR-conditional labeling for previously implanted systems.

Last June, Boston Scientific said it’s launched a global clinical trial for its 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.

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