2013-05-06 15:07:02 -
Newly designed Devices Result in Fewer Hospitalizations for Patients, Deliver
Increased Longevity, and Improved Comfort
MINNEAPOLIS - May 6, 2013 - Medtronic, Inc.
(NYSE: MDT) today announced U.S. Food and Drug
Administration (FDA) approval and U.S. launch Click to view multi-media
of its newest cardiac devices: version of this release.
the Viva®portfolio of cardiac resynchronization
therapy with defibrillation (CRT-D) devices,
and the Evera® portfolio of implantable
The Viva CRT-D significantly improves response
rate to the therapy for many indicated heart
failure patients, with a demonstrated
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
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-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.
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
addition, both systems are paired with the reliable Sprint Quattro® Secure lead,
the only defibrillator lead with 10 years of proven performance with active
"These devices offer patients and physicians advanced systems that can improve
patients' overall quality of life, while reducing the cost burdens of
unnecessary hospitalizations," said Jagmeet P. Singh, M.D., Ph.D., director of
the resynchronization and advanced cardiac therapeutics program at Massachusetts
General Hospital in Boston. "Patients can now experience a more comfortable fit
due to less skin pressure, a longer lasting battery, and highly advanced CRT-D
The Viva and Evera portfolios include SmartShock(TM) 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.()
"These devices are designed to provide optimal therapy for patients, while
providing economic benefits through fewer hospitalizations, fewer inappropriate
shocks and increased longevity, which can result in lower healthcare costs,"
said David Steinhaus, M.D., vice president and general manager, Heart Failure,
and medical director for the Cardiac Rhythm Disease Management business at
Medtronic. "Patients suffering from debilitating heart rhythm disorders can rely
on new treatment options that can significantly improve their quality of life."
In collaboration with leading clinicians, researchers and scientists worldwide,
Medtronic offers the broadest range of innovative medical technology for the
interventional and surgical treatment of cardiovascular disease and cardiac
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology - alleviating pain, restoring health, and extending
life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
To view a multi-media version of this release, including additional background
information and downloadable photos, click here.
 Nationwide Inpatient Sample (NIS), Healthcare Cost and Utilization Project
(HCUP), Agency for Healthcare Research and Quality (AHRQ). 2010 Data Year.
Available On-Line at: hcupnet.ahrq.gov/HCUPnet.jsp
. Accessed on April
 Tarab AD, et al. ISPOR 2012
 Singh JP, Shen J, Chung. ES. Clinical response with Adaptive CRT algorithm
compared with echo guided AV optimization: a propensity score analysis of multi-
center trials. Presentation at European Society of Cardiology Congress August
 Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file.
 Knops P, Theuns DA, Res JC, Jordaens L. Analysis of implantable
defibrillator longevity under clinical circumstances:implications for device
selection. Pacing Clin Electrophysiol. October 2009;32(10):1276-1285.
 Schaer BA, Koller MT, Sticherling C, Altmann D, Joerg L, Osswald S.
Longevity of implantable cardioverterdefibrillators,influencing factors, and
comparison to industry-projected longevity. Heart Rhythm. December
 Biffi M, Ziacchi M, Bertini M, et al. Longevity of implantable cardioverter-
defibrillators: implications for clinical practice and health care
systems. Europace. November 2008;10(12):1288-1295.
 Kallinen L, et al.
 Thijssen J, Borleffs CJ, van Rees JB, et al. Implantable cardioverter-
defibrillator longevity under clinical circumstances: an analysis according to
device type, generation, and manufacturer. Heart Rhythm. April
 Shafat T, Baumfeld Y, Novack V, Konstantino Y, Amit G. Significant
differences in the expected versus observed longevity of implantable
cardioverter defibrillators (ICDs). Clin Res Cardiol. Published online July
 Horlbeck FW, Mellert F, Kreuz J, Nickenig G, Schwab JO. Real-world data on
the lifespan of implantable cardioverter-defibrillators depending on
manufacturers and the amount of ventricular pacing. J Cardiovasc Electrophysiol.
 Evera XT DR/VR Manual.
 Medtronic Product Performance Report, 2012 Second Edition, Issue 66.
 Virtual ICD: A Model to Evaluate Shock Reduction Strategies. Presented at
HRS 2010 (P03-125).
Viva and Evera hi-res image:
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Source: Medtronic, Inc. via Thomson Reuters ONE