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St. Jude Medical gets FDA approval for heart-failure devices
By Elaine Rigoli
Tampa, Fla., July 18 - St. Jude Medical, Inc. announced Food and Drug Administration approval of new devices for treating patients with potentially lethal heart arrhythmias and heart failure: the Atlas II ICD (implantable cardioverter defibrillator) and the Atlas II HF CRT-D (cardiac resynchronization therapy defibrillator).
The company said it will start selling both devices in the United States in August.
The company said the new devices feature enhanced telemetry speed for faster communications - up to five times faster than predecessor devices - which may result in more convenient follow-up visits for patients and physicians.
In addition, the new Atlas devices include a "patient notifier" that gently vibrates to alert patients, including those who have difficulty hearing, of critical changes in device function so they know to contact their physicians.
St. Paul, Minn.-based St. Jude Medical develops and provides medical device technology and services.
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