“The recent FDA approval expanding the indication of our CRT-D devices – coupled with this strong economic data – showcases our commitment to treating heart failure and enhancing patient outcomes at every stage of care with our innovative portfolio of CRT-D therapies,” said David Steinhaus, M.D., Vice President and General Manager, Heart Failure, and Medical Director for the Cardiac Rhythm Disease Management business, Medtronic. “With the rising cost of healthcare significantly impacting our global economy, it is critically important to provide high-value, safe, effective therapies like CRT-D, that provide significant improvements at cost thresholds deemed acceptable to health care decision makers, as this analysis demonstrated.”The economic analysis assessed the healthcare-related costs and QALYs of 1,798 patients randomized to receive CRT-D or ICD therapy extrapolated across a lifetime horizon, which was facilitated by an economic model that combined RAFT patient data with long-term data on the longevity of the medical devices. Cost in regard to QALYs was discounted at 3 percent per year. Healthcare-related costs examined included the treatment device (plus any replacements), hospitalization (both cardiovascular and non-cardiovascular related), pharmaceutical treatments, physician visits and long-term care, and were calculated using U.S. expenditures. About the RAFT Trial The RAFT trial, sponsored by the Canadian Institutes of Health Research and Medtronic, is a double-blinded, randomized, controlled trial, and showed that CRT-D significantly reduced mortality for mildly symptomatic heart failure patients (NYHA Class II): 29 percent when compared to patients treated with guideline-recommended implantable ICDs and medical therapy (p=0.006; HR=0.71). The study also demonstrated a significant reduction (30 percent) in heart failure hospitalizations for this Class II population (p=0.003; HR=0.70), consistent with previously published studies. It involved 1,798 patients in Canada, Europe and Australia. All patients were followed for at least 18 months, and had an average follow-up of 40 months, making it the longest follow-up and largest patient months-of-experience of any randomized controlled trial of CRT therapy. In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.
About Medtronic 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 results. 1 The Economic Argument for Disease Prevention: Distinguishing Between Value & Savings. Partnership for Prevention. February 2009. Retrieved on April 9, 2012 from http://www.prevent.org. 2 American Heart Association / American Stroke Association, Heart Disease and Stroke Statistics, 2010 Update.