St. Jude Wins Expanded EU Indication for MRI-Compatible Cardiac Devices

St. Jude Medical said Wednesday that it has been granted an expanded CE mark indication for its Ellipse implantable cardioverter defibrillator and Durata and Optisure defibrillation leads allowing their use in patients undergoing MRI scans.

The Ellipse ICD treats life-threatening arrhythmia using the firm’s DYnamicTx algorithm, which automatically adjusts shock configurations if an electrical short occurs. The device’s coating has significantly reduces friction between the device and leads, lessening lead-to-can abrasion — a common type of insulation failure.

The new indication dovetailed with CE mark approval of St. Jude’s Assurity MRI and Endurity MRI pacemakers. The devices are the smallest, longest-lasting wireless pacemakers in the world, according to the company. — Jason Scott