April, 2011 – Dr. Charles Lanzarotti, an electrophysiologist at Wheaton Franciscan Healthcare – St. Francis, became the first physician in Wisconsin to treat patients who suffer from serious, often life-threatening irregular heartbeats with a new advanced freezing technology using a cryoballoon.


Dr. Lanzarotti appeared on TMJ4 Positively Milwaukee to discuss the Cryoballoon treatment.

The Cryoballoon treatment, called The Arctic Front® Cardiac CryoAblation Catheter system, is the first and only Cryoballoon in the United States indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). The Cryoballoon involves a minimally-invasive procedure that efficiently creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.

Balloon-based technology is novel because it ablates or blocks the conduction of atrial fibrillation (AF) in cardiac tissue through the use of a coolant rather than heat, which is delivered through a catheter. This freezing technology allows the catheter to adhere to the tissue during ablation, allowing for greater catheter stability.

This unique ablation approach fills an unmet need in AF ablation by providing a straightforward and efficient approach to pulmonary vein isolation, while giving patients a new, minimally-invasive treatment approach proven to be safe and effective.

The FDA approval of the Arctic Front System was based on the pivotal STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial, which demonstrated the safety and efficacy of the device in treating and eradicating paroxysmal atrial fibrillation. The study showed that 69.9 percent of patients treated with Arctic Front were free from atrial fibrillation at one year, compared to 7.3 percent of patients treated with drug therapy only. The study also demonstrated that treatment with the device is safe, with limited procedure-related adverse events (3.1 percent), and patients enrolled in the study displayed a significant reduction of symptoms, a decrease in the use of drug therapy and substantial improvements in both physical and mental quality-of-life factors.


About the Arctic Front Cardiac CryoAblation Catheter System
The Arctic Front Cardiac CryoAblation Catheter System is designed to be used with fluoroscopy and does not require the use of complex, three-dimensional mapping systems. The technologies offered 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, 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 in America. Approximately 3 million Americans are estimated to have the disease, and about 40 percent don’t exhibit symptoms and may be under-diagnosed.

Half of all diagnosed atrial fibrillation patients fail drug therapy , and if left untreated patients have up to a five times higher risk of stroke and an increased chance of developing heart failure. Additionally, since atrial fibrillation is often age-related, as the U.S. population continues to grow older, the need for more effective treatment options is escalating.