FDA approves Viva and Evera defibrillators for Heart Failure

Medtronic, Inc. announced FDA approval and U.S. launch on 6 May 2013 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. According to economic analyses presented at ISPOR Europe, with this device both payers and hospital providers will experience reductions in overall healthcare costs as compared to CRT-D devices with traditional programming. The improved response is due to the device's ability to continuously adapt to individual patient needs and preserve each patient's normal heart rhythms. Called AdaptivCRT, the algorithm improves heart failure patients' response rate to CRT-D therapy by 12 percent as compared to historical CRT trials.