Download BACKGROUNDER The Medtronic Arctic Front® Cardiac

BACKGROUNDER
The Medtronic Arctic Front® 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 heart 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 Arctic Front ® Cardiac CryoAblation Catheter System is the industry’s first
cryoablation system in the United States indicated to treat drug refractory recurrent
symptomatic paroxysmal atrial fibrillation (PAF), a serious heart rhythm disorder that
affects millions of Americans. Arctic Front releases coolant into the catheter’s balloon 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 Cryoballoon is
simpler and less technically demanding for physicians to use 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 CryoAblation Catheter System
The Arctic Front Cryoballoon is designed to be used with fluoroscopy and does not
require the use of complex, three-dimensional mapping systems. The technologies used
in the system include:
• The Arctic Front Cryoballoon, which inflates and fills with coolant to ablate the
tissue where the pulmonary veins enter the left atrium;
• The FlexCath ® Steerable Sheath, which helps deliver and position the
cryocatheter in the left atrium;
• The Freezor ® MAX Cardiac CryoAblation Catheter, 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
###
1
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.
2