|FIRE AND ICE Analysis: Lower Healthcare System Costs with Medtronic Cryoballoon|
Late Breaking Clinical Trial Demonstrates Favorable Health Economics and Positive Clinical Outcomes for AF Patients
DUBLIN AND SEOUL, REPUBLIC OF KOREA - Oct. 13, 2016 - Medtronic plc (NYSE:MDT) today unveiled new health economic analysis data from the FIRE AND ICE trial that favor cryoballoon catheter ablation over radiofrequency (RF) ablation related to trial period cost savings as a result of fewer cardiovascular (CV) rehospitalizations and repeat ablations. The data were presented at a late-breaking clinical trial session at the Asia Pacific Heart Rhythm Society's Scientific Sessions in Seoul, Republic of Korea.
The new analyses show that the Arctic Front® Cryoballoon Catheter Family reduces payer costs across multiple healthcare systems, compared to the ThermoCool® line of RF ablation catheters. Investigators also examined the association between baseline patient demographics and CV rehospitalizations to determine if the primary and secondary trial results were consistent across patient subgroups.
"The cryoballoon technology demonstrates cost savings across multiple health systems, driven by a reduction in post-procedure rehospitalizations and reinterventions due to their underlying disease state," said Prof. Karl-Heinz Kuck, M.D., director of cardiology at Asklepios Klinik St. Georg, Hamburg, Germany, and principal investigator of the trial. "These analyses highlight the real-world patient outcomes and health system benefits of the cryoballoon."
The primary results from the FIRE AND ICE trial were published in The New England Journal of Medicine and showed comparable safety and effectiveness of cryoballoon ablation and RF catheter ablation1. Secondary analyses, which demonstrated significantly fewer repeat ablations and lower cardiovascular hospitalization rates with cryoablation, were published in the European Heart Journal2.
Health Economic Supplementary Analysis
"We are committed to leading the global shift to value-based healthcare, which means we want to be measured by the impact we have both on patient outcomes as well as the economic value we create for the healthcare system," said Colleen Fowler, vice president and general manager of the AF Solutions business, part of the Cardiac and Vascular Group at Medtronic. "Today's findings further underscore the ability of the cryoballoon to make a difference in care across patients, physicians and healthcare systems."
About FIRE AND ICE
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. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers 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.
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1 Kuck KH, Brugada J, Fürnkranz A, et al. N Engl J Med 2016; 374:2235-2245 June 9, 2016 DOI: 10.1056/NEJMoa1602014