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Medtronic Receives FDA Approval and CE Mark for Arctic Front Advance® ST Cryoballoon to Treat Atrial Fibrillation

Press releases may be edited for formatting or style | May 12, 2015

About the Arctic Front Advance System
The Arctic Front Advance System is the only cryoballoon system approved in the U.S. for the treatment of paroxysmal atrial fibrillation and in Europe for treatment of atrial fibrillation. It has been used to treat more than 120,000 patients in more than 50 countries worldwide. The technologies currently offered as part of the system include:
The Artic Front Advance ST Cryoballoon, which isolates the pulmonary veins for the treatment of atrial fibrillation;
The FlexCath Advance(TM) Steerable Sheath, which helps deliver and position the cryoballoon in the left atrium;
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The Achieve® Mapping Catheter, an intra-cardiac electrophysiology recording catheter used to assess pulmonary vein isolation when treating paroxysmal atrial fibrillation;
The Freezor® MAX Cardiac Cryoablation Catheter, which is a single-point catheter used to provide additional ablations, as needed; and
The CryoConsole, which houses the coolant, electrical and mechanical components that run the catheters during a cryoablation procedure.

About Atrial Fibrillation
Atrial fibrillation is the most common and one of the most undertreated heart rhythm disorders, affecting more than 33.5 million people worldwide.5 It is estimated that half of all diagnosed atrial fibrillation patients fail drug therapy6, and if left untreated, patients have up to a five times higher risk of stroke and an increased chance of developing heart failure7.

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.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, 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 Xu J, Huang Y, Cai H, Qi Y, Jia N, Shen W, Lin J, Peng F, Niu W. Is cryoballoon ablation preferable to radiofrequency ablation for treatment of atrial fibrillation by pulmonary vein isolation? A meta-analysis. PLoS One 2014;9(2):e90323.
2 DeVille JB, Comparison of Resource Utilization of Pulmonary Vein Isolation: Cryoablation versus RF ablation with Three-Dimensional Mapping in the Value PVI Study. JIC. June 2014

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