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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 100,000 patients in approximately 800 centers across 40 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
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Millennium Research Report; “Global Markets For Atrial Fibrillation Treatment Devices 2008,” March 2008; 1.
2001; 285:2370-5.
3 Fuster et al. Journal of the American College of Cardiology. 2006; 48:854-906.
1
2JAMA