St. Jude Medical on Monday announced European CE Mark approval of the Assura family of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The Assura devices feature a technology that helps protect patients against inappropriate shocks.
Officials at St. Jude said that the new technology is projected to reduce inappropriate therapy by 74 percent. Products currently available in Europe include the Quadra Assura CRT-D, Unify Assura CRT-D and Fortify Assura ICD.
ICDs are implantable cardiac devices that treat abnormally fast, potentially lethal heart rhythms that can lead to sudden cardiac death if left untreated. A CRT-D device resynchronizes the beat of the heart’s lower chambers, which often beat out of sync in heart failure patients. A CRT-D also provides back up treatment for sudden cardiac death.
“With the three new discriminators and highest amount of delivered energy, the Assura devices provide the ideal combination of intelligence and strength. These devices offer unique features that I believe will help protect my patients from inappropriate shocks and provide greater defibrillation therapy assurance,” said Dr. Klaus-Jürgen Gutleben, Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen, Germany.
St. Jude Medical is a worldwide maker of medical technology headquartered in Little Canada.