|Five-Year Analysis of Pivotal REVERSE Trial Demonstrates Long-Term Clinical Benefits of Medtronic CRT-D Therapy in Mild Heart Failure Patients|
Low Mortality and Heart Failure Hospitalization Sustained at 5-Years Post Implant with Medtronic CRT-D Devices
MUNICH, GERMANY – August 27, 2012 – Medtronic, Inc. (NYSE: MDT) today announced findings from a new clinical analysis of the pivotal REVERSE (Resynchronization Reverse Remodeling in Systolic Left Ventricular Dysfunction) trial, which demonstrated that its cardiac resynchronization therapy (CRT) devices are associated with low mortality and heart failure hospitalization rates over 5 years, post-implant. This is the first – and longest – study of its kind to show that CRT results in significant structural changes to the heart in patients with mild disease (at 2 years following implant), and also had positive, enduring long-term effects. The 5-year data was presented today at the European Society of Cardiology’s ESC Congress 2012 in Munich.
“These findings show, for the first time, the overall magnitude of the long-lasting, lifesaving benefits of CRT in a mildly symptomatic patient population,” said Cecilia Linde, M.D., Ph.D., of Karolinska University Hospital in Stockholm, and principal investigator in the trial who presented the new data at ESC. “This noteworthy data adds to the growing body of evidence further validating the clinical benefits of early intervention with CRT and confirms the sustaining benefit that patients can continue to receive over a 5-year time-span.”
Throughout the REVERSE study, the benefits of CRT persisted, indicating that the device therapy reduces disease progression in patients with mildly symptomatic (New York Heart Association/NYHA-designated Class I and II) heart failure for at least 5 years following implant. Patients whose CRT was immediately activated at the beginning of the trial experienced a 5-year mortality rate of 13.5 percent, and a death plus heart failure-related hospitalization rate of 28.1 percent. These rates are lower than those observed in other landmark CRT clinical trials with similar patient populations1.
Heart failure patients suffer from enlarged hearts and, in the study, CRT therapy was shown to reverse this cardiac enlargement and sustain the reversal over time, as measured by the left ventricular end systolic volume index (LVESVi). In REVERSE, the change was greatest within the first 2 years of therapy and thereafter sustained.
“The REVERSE trial continues to provide the medical community with valuable, real-world insight on the benefits of CRT in providing optimal treatment to patients with early-stage heart failure,” said David Steinhaus, M.D., vice president, general manager and medical director for the Cardiac Rhythm Disease Management business. “We are committed to providing physicians with the most advanced medical devices – backed by strong clinical data – to treat heart failure patients across the continuum of care, whether in the earliest or most severe stages of disease.”
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Sudden cardiac arrest (SCA) is responsible for more than 60 percent of deaths among patients with mild-to-moderate heart failure. However, research suggests that earlier intervention with CRT-D can decrease the risk of morbidity and mortality in this mildly symptomatic patient population. CRT-D therapy works by resynchronizing the contractions of both ventricles by sending tiny electrical impulses to the heart muscles, which improves the heart’s blood-pumping ability. The device also has defibrillation capability, allowing for termination of life-threatening ventricular arrhythmias.
About the REVERSE Trial
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 arrhythmias.
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 results.
1 Each of these trials involved distinct clinical study protocols.
Kathleen Janasz, Public Relations, 763-526-3676
Jeff Warren, Investor Relations, 763-505-2696