Medtronic of Canada Ltd. today announced that Health Canada has approved its Arctic Front® Cardiac CryoAblation Catheter System, the first and only Cryoballoon in Canada indicated for the treatment of patients suffering from paroxysmal atrial fibrillation (PAF). The Cryoballoon treatment 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.

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

"Cryoballoon technology is a major improvement over the traditional focal approach for the treatment of atrial fibrillation," said Dr. Marc Dubuc, Cardiologist and Electrophysiologist at the Montreal Heart Institute and Associate Professor at the Faculty of Medicine, University of Montreal. "The delivery of circumferential lesions around the pulmonary veins reduces the duration of the procedure while being effective and safe."

The Health Canada 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 the Arctic Front System 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, when used as indicated, 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.

"We are pleased with the success we obtained using cryoablation in the North American STOP AF trial, and our patients have done extremely well," said Dr. Peter Guerra, Cardiologist and Chief of Electrophysiology Service at the Montreal Heart Institute and Assistant Professor in the Faculty of Medicine at the University of Montreal. "Now, at last, we can offer this technology to all our patients. Since cryoablation for cardiac ablation was pioneered at the Montreal Heart Institute, we are anxious to move forward with this new tool."

Dr. Jean Champagne, Cardiologist and Electrophysiologist at The Institut Universitaire de Cardiologie et Pneumologie de Québec added, "It has been four years since I treated my first patient with the Arctic Front balloon as part of the STOP AF trial, and in my experience it allows for deeper lesions, has a higher healing rate than our current ablation technique and leads to very few long-term atrial fibrillation recurrences. We are pleased that this technology has finally been accepted in Canada and is now available to our patients."

Medtronic acquired Montreal-based CryoCath Technologies, Inc. and U.S.-based Ablation Frontiers, Inc., to form Medtronic's AF Solutions division within the Cardiac Rhythm Disease Management business. When combined with Medtronic's existing EP Systems product portfolio, AF Solutions offers an extensive line of diagnostic, cryoablation (freezing technology) and radiofrequency ablation tools to diagnose and treat a broad spectrum of cardiac arrhythmias.

"This system was designed, developed and manufactured in Canada with a global mandate, including supplying the US and Europe," said Neil Fraser, President of Medtronic of Canada. "We are very excited this novel technology, which has already been used to treat more than 15,000 patients in more than 200 centers outside of Canada, is now also approved in this country."

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

- Approximately 250,000 Canadians are estimated to have atrial fibrillation1, which is the most common type of arrhythmia2. Atrial fibrillation accounts for 49% of arrhythmia-related hospital stays and more days in the hospital than all other arrhythmias combinedi.

Half of all diagnosed atrial fibrillation patients fail drug therapy3, and if left untreated patients have up to a five times higher risk of stroke4 and an increased chance of developing heart failure. Additionally, since atrial fibrillation is often age-related, as the Canadian population continues to grow older, the need for more effective treatment options is escalating.

Paroxysmal atrial fibrillation (PAF) is a type of atrial fibrillation in which irregular heartbeats in the upper chambers start and stop suddenly on their own, usually for minutes or days at a time.

1. Humphries K et al. Can J Cardiol Vol 20 No 9 July 2004

2. See here. (accessed April 2011)

3. JAMA 2001; 285:2370-5.

4. Fuster et al. Journal of the American College of Cardiology. 2006; 48:854-906.

Source:
Medtronic, Inc.
Medtronic of Canada Ltd.