St. Jude gets CE Mark for updated labeling of pacing leads

St. Jude Medical announced CE Mark approval of updated labeling for its Tendril STS and IsoFlex Optim pacing leads, which allows existing and future patients with the devices access to MR imaging.

The leads are used with the Accent MRI pacemaker. They are built with Optim insulation material, a hybrid that blends silicone rubber with polyurethane. This combination is designed to provide increased durability and improve flexibility.

St. Jude Medical also plans to seek updated labeling for its Fortify Assura implantable cardioverter defibrillator (ICD), Ellipse ICD, Quadra Assura cardiac resynchronization therapy defibrillator, and Durata and Optisure defibrillation leads.

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