|FIRE AND ICE Trial Analysis Shows Medtronic Cryoballoon Reduces Healthcare System Costs and Utilization|
Data from Landmark Trial Published in the Journal of the American Heart Association
DUBLIN - August 1, 2017 - A new health economic analysis from the landmark FIRE AND ICE Trial, sponsored by Medtronic plc (NYSE: MDT), was published today in the Journal of the American Heart Association. The data show that treating paroxysmal atrial fibrillation (AF) with cryoballoon catheter ablation may result in substantial cost savings as compared to radiofrequency (RF) ablation. These findings were driven by fewer repeat ablations and cardiovascular (CV) rehospitalizations in patients treated with the cryoballoon and were consistently observed in multiple healthcare systems internationally included in the analysis.
The analysis - building on data originally presented as a late-breaking clinical trial at the 2016 Asia Pacific Heart Rhythm Society Scientific Sessions - supports the economic value of cryoballoon ablation with the Medtronic Arctic Front(TM) Cryoballoon Catheter Family compared to RF ablation with the ThermoCool® line of RF ablation catheters.
"These findings show that patients treated with the cryoballoon have positive clinical outcomes such as fewer rehospitalizations and ablations, leading to decreased burden on health systems and lower costs," said Prof. Karl-Heinz Kuck, M.D., director of cardiology at Asklepios Klinik St. Georg, Hamburg, Germany, and principal investigator of the trial. "The latest analysis further validates cryoablation as an effective treatment option for AF patients with real economic value across health systems."
Health Economic Supplementary Analysis
"This analysis illustrates the Medtronic cryoballoon's sustained economic impact across multiple healthcare systems - improving patient outcomes with reduced healthcare utilization and lowering healthcare system costs," said Colleen Fowler, vice president and general manager of the AF Solutions business, part of the Cardiac and Vascular Group at Medtronic.
About FIRE AND ICE
About the Arctic Front Advance Cryoballoon
The 2016 European Society of Cardiology's (ESC) guidelines and recent 2017 Heart Rhythm Society (HRS) Consensus Statement for the management of atrial fibrillation both acknowledge cryoablation therapy for AF, and recognize pulmonary vein isolation (PVI) as an effective and preferred treatment option for select patients with AF.
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
2 Kuck KH, Fürnkranz A, Chun J, et al. Eur Heart J (2016) ehw285 DOI: http://dx.doi.org/10.1093/eurheartj/ehw285 First published online: 5 July 2016