FDA Approves 2 St. Jude Heart Devices


The Food and Drug Administration has approved St. Jude Medical's new Ellipse implantable cardioverter defibrillator (ICD) and its Assura cardiac resynchronization therapy defibrillator (CRT-D), high-voltage devices with new safety features.

According to St. Jude's press release yesterday, the products are designed to promote effectiveness in providing electronic shock therapy while reducing safety risks.

The approvals come as St. Jude's cardiovascular rhythm management (CRM) division, which includes these and similar devices, has faced significant sales pressure. St. Jude's CRM revenue fell by around 6% last year.

St. Jude's U.S. approvals come after the company received European CE Mark approval for the Ellipse and Assura last year. The Ellipse and other ICDs are designed to treat abnormal heart rates, while Assura and other CRT-Ds are designed to manage irregularities in the beating of the heart's lower chambers. Both conditions, if untreated, can lead to potentially fatal outcomes such as sudden cardiac death and heart failure.

The company promises increased safety with the new devices. Dr. Eric S. Fain, president of St. Jude's Implantable Electronics Systems Division, was quoted as saying, "St. Jude Medical strives to deliver the highest levels of patient safety. The new Ellipse ICD and SJM Assura family of devices support those efforts by providing added features that ensure effective therapy delivery."


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