Download Arctic Front Advance™ Cardiac Cryoballoon Backgrounder

 BACKGROUNDER The Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheter System Overview A catheter ablation is a minimally invasive procedure that aims to treat atrial fibrillation (AF), an irregular quivering or rapid rhythm in the upper chambers (atria) of the heart. The goal of the procedure is to stop the rapid beating of the upper heart chambers by ablating, or blocking the conduction of AF by isolating the pulmonary vein. The second‐generation Arctic Front Advance™ Cardiac CryoAblation Catheter System builds on the industry’s first cryoballoon system indicated to treat drug refractory (resistant) recurrent symptomatic paroxysmal atrial fibrillation (PAF), a serious heart rhythm disorder that affects 7 million people worldwide. The Arctic Front Advance Cryoballoon utilizes coolant to freeze and ablate the tissue, rather than creating lesions with radiofrequency or heated energy with a point‐by‐point catheter. The freezing helps the balloon maintain contact with the heart tissue during the procedure. Physician and Patient Benefits A leading advancement from currently available ablation tools, the Arctic Front Advance Cryoballoon provides a more straightforward approach to pulmonary vein isolation than a point‐by‐point catheter. The procedure is proven safe and effective in isolating the pulmonary veins to stop AF in patients who have previously failed drug treatment. About the Medtronic Arctic Front Advance CryoAblation Catheter System The Arctic Front Advance Cryoballoon System and its predecessor have been used to treat more than 50,000 patients in approximately 500 centers across 32 countries. The technologies currently offered include:  The Arctic Front Advance Cryoballoon, which inflates and fills with coolant to ablate the tissue where the pulmonary veins enter the left atrium;  The FlexCath Advance™ Steerable Sheath, which helps deliver and position the cryocatheter in the left atrium;  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. Atrial Fibrillation Overview and Statistics  Atrial fibrillation is a quivering or rapid heart rhythm in the upper chambers (atria) of the heart.  AF causes inefficient pumping of the heart and can lead to other rhythm problems as well as chronic fatigue, difficulty breathing and heart failure.  AF is the most common heart arrhythmia affecting more than 3 million Americans and 7 million people worldwide.1  Half of all diagnosed AF patients fail drug therapy.2  Untreated AF patients have a five times higher risk of stroke.3 # # # Millennium Research Report; “Global Markets For Atrial Fibrillation Treatment Devices 2008,” March 2008; 1. JAMA 2001; 285:2370‐5. 3 Fuster et al. Journal of the American College of Cardiology. 2006; 48:854‐906. 1
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