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Home Treated Conditions Bradycardia Medtronic Announces FDA Approval of Next-Generation CRT-D and ICD IPG Families
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Medtronic Announces FDA Approval of Next-Generation CRT-D and ICD IPG Families

Medtronic Evera ICD www.implantable-device.com David Prutchi PhD

Medtronic announced today the FDA approval of its new Viva® portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).  According to the press release:

“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.

The next-gen Viva CRT-Dand 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.

Building upon its industry-leading device longevity as proven by seven independent studies, Medtronic’s Viva and Evera systems deliver up to a 25-percent increase in battery longevity (up to 11 years) compared to previous devices. In addition, both systems are paired with the reliable Sprint Quattro® Secure lead, the only defibrillator lead with 10 years of proven performance with active monitoring.”

 
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