BACKGROUNDER: The Medtronic Arctic Front® Cardiac CryoAblation Catheter System
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.
2JAMA 2001; 285:2370-5.
3 Fuster et al. Journal of the American College of Cardiology. 2006; 48:854-906.
FACT SHEET: Atrial Fibrillation
Atrial ﬁbrillation (AF or AFib), is the most common and one of the most undertreated heart rhythm disorders in America. The disease, which involves an irregular quivering or rapid heart rhythm in the upper chambers (atria) of the heart, is found in approximately 3 million Americans and 7 million people worldwide. A heart in AF beats signiﬁcantly faster than a normal heartbeat. When the heart does not contract at a normal rhythm, blood is not pumped completely out of the atria and may pool and clot.
When left untreated, AF patients have a ﬁve times higher chance of having a stroke, and are at greater risk of developing heart failure. Additionally, since AF causes inefﬁcient pumping of the heart, the disease can lead to other heart rhythm problems as well as chronic fatigue. People with other heart rhythm disorders, such as slow heart rates called bradycardia and fast heart rates in the ventricles called ventricular tachycardia, may also have AF.
Three Types of AF
• Paroxysmal AF occurs when the rapid rhythm in the heart’s upper chambers start and stop suddenly, usually for minutes or days at a time.
• Persistent AF occurs when the heart’s upper chambers beat erratically for more than seven days and medical intervention or drug therapy is needed to stop the episode.
• Permanent or continuous AF occurs when the heart’s upper chambers consistently beat erratically at very high rates. This is the most severe form of AF.
AF Risk Factors & Symptoms
The most common risk factor associated with AF is existing heart disease. AF is common among people who suffer from coronary heart disease, valve disease, an inﬂamed heart muscle or lining, or those who have had a heart attack, congestive heart failure or heart surgery.
Other risk factors include high blood pressure, clogged arteries, diabetes, overactive thyroid, emphysema or other lung diseases, viral infections, sleep apnea, stress, fatigue and age.
While medication has been considered the ﬁrst-line treatment for AF, clinical research indicates that half of all patients with symptomatic disease fail drug therapy. New medical technologies have the potential to provide patients with better treatment options and reduce the risks of stroke, heart failure and death.
Following is an overview of various AF treatment methods used worldwide:
• Medication for AF patients is designed to regain and maintain normal heart rhythm, control the heart rate (pulse), and prevent stroke.
• Cardioversion, traditionally used with persistent AF patients, delivers small, timed electrical shocks to the heart to restore normal rhythms. This procedure is performed while the patient is in the hospital.
• An implantable deﬁbrillator or pacemaker, small, stopwatch-sized devices placed under the skin in the upper chest, deliver electrical shocks or painless pacing therapy that can restore the heart’s rate and deliver life-saving therapy. With all types of AF patients, implantable devices may be used after an ablation procedure.
• Cryoablation, a minimally invasive catheter approach that freezes tissue in the heart’s upper chambers, traditionally around the pulmonary vein for AF treatment, to block the conduction of electrical signals that trigger erratic heart rhythms.
• Surgical Intervention*, traditionally an open-heart surgical procedure called the Cut and Sew Maze, includes a series of atria incisions in a maze-like pattern intending for the scars to serve as blocks for the abnormal electrical pathways. More common today is surgical ablation on the heart’s surface either at the same time as other heart disease treatments (open heart surgery) or stand-alone through a small port-size incision.
• Radiofrequency (RF) Ablation,* a minimally invasive catheter approach that delivers radiofrequency energy to destroy the abnormal electrical paths in the heart. RF ablation is the most common interventional (or curative) treatment worldwide for all types of AF. Most AF ablation procedures focus on destroying cells around the pulmonary vein (PV) to block or isolate the abnormal electrical paths.
Millenium Research Report; “Global Markets For Atrial Fibrillation Treatment Devices 2008,” March 2008; 1.
ACC/AHA/ESC Guidelines for the Management of Patients with Atrial Fibrillation
JAMA 2001; 285:2370-5