Medical device maker Medtronic Inc. (MDT) on Monday announced U.S. Food and Drug Administration approval and U.S. launch of its newest cardiac devices: the Viva portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera portfolio of implantable cardioverter-defibrillators (ICD).
The Viva CRT-D significantly improves response rate to the therapy for many indicated heart failure patients, with a demonstrated 21 percent reduction in overall heart failure hospitalizations within the first year after implant as compared to historical CRT trials.
The next-gen Viva CRT-D and Evera defibrillation devices are shaped for patient comfort with a new, contoured design that reduces skin pressure by 30 percent, deliver greater battery longevity and come equipped with the most advanced shock reduction technology available. The devices deliver up to a 25-percent increase in battery longevity (up to 11 years) compared to previous devices.
The Viva and Evera portfolios include SmartShock 2.0, the next generation shock reduction algorithm that enables devices to better differentiate between dangerous and harmless heart rhythms, resulting in a 98-percent inappropriate shock free rate at one year.
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