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St. Jude Medical Receives FDA Approval For Its Cardiac Therapies

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St. Jude MedicalSt. Jude Medical has received the U.S. Food and Drug Administration (FDA) approval and first U.S. implants of its Unify™ cardiac resynchronization therapy defibrillator (CRT-D) and Fortify™ implantable cardioverter defibrillator (ICD).

“These devices offer a number of new features designed to address many of the clinical issues facing our patients while still delivering the reliability, power and longevity I expect from a St. Jude Medical device,” said Dr. Robert P. Styperek, F.A.C.C., Harbin Clinic Physician, Director of Electrophysiology, at Redmond Regional Medical Center in Rome, Ga.

The Unify CRT-D and Fortify ICD have 45J of stored energy and can deliver 40J, the highest energy of any ICD. ICD is an advanced implantable device that treats potentially lethal, abnormally fast heart rhythms, which often lead to sudden cardiac death (SCD).

Moreover, the two devices are designed to decrease unnecessary defibrillation therapy, while ensuring effective therapy occurs when the patient needs it, in order to convert fast ventricular arrhythmias painlessly and avoid the need for high voltage shocks.

Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division, said "Our goal with these product lines is to provide physicians with solutions that address their most significant clinical challenges, including patient safety and inappropriate therapy, and to do so while reducing the size of the device."

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