The FDA approved the Emblem MRI subcutaneous implantable defibrillator system (Boston Scientific) on August 9. The agency also approved magnetic resonance labeling for previously implanted Emblem S-ICD systems.
The Emblem MRI S-ICD system features magnetic resonance-conditional labeling as well as an updated technology that ensures patients receive the appropriate therapy and a detection tool that tells physicians when patients are identified as having atrial fibrillation.
In March 2015, the FDA approved the Emblem S-ICD system, which is indicated to treat patients at risk of sudden cardiac arrest.
Kenneth Stein, MD, Boston Scientific’s chief medical officer, said in a news release that the FDA approvals mean patients “can safely undergo MR scans while remaining protected from cardiac arrest.”
In April, the FDA approved Boston Scientific’s ImageReady MR-conditional pacing system to treat patients with bradycardia. The company has also launched the Enable MRI study, which it hopes will lead to FDA approvals for MRI compatibility with its currently approved implanted cardiac defibrillation and cardiac resynchronization therapy systems.