Healthcare Industry News:  Cryoballoon 

Devices Cardiology

 News Release - September 25, 2012

First Case Completed Using Arctic Front Advance(TM) Cardiac Cryoballoon System for the Treatment of Paroxysmal Atrial Fibrillation

Next-Generation Technology Reinforces Safety and Efficacy While Improving Procedure Efficiency

POINTE-CLAIRE, QUEBEC--(Healthcare Sales & Marketing Network) - Canadians now have a new option for the treatment of paroxysmal atrial fibrillation (PAF) using the Arctic Front Advance™ Cardiac CryoAblation System, an innovative Cryoballoon therapy developed and manufactured in Quebec. The first case in Canada was successfully completed at the Montreal Heart Institute in early September.

The second generation Arctic Front Advance Cardiac Cryoballoon System provides a more efficient approach to treating PAF, building upon the original Arctic Front® Cardiac CryoAblation System. It is the only Cryoballoon system currently available worldwide, for the treatment of Paroxysmal atrial fibrillation (PAF).

"I was impressed by how quickly we completed the procedure with the Arctic Front Advance Cardiac CryoAblation System. This is a significant improvement over existing technologies," explained 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.

The Arctic Front Advance Cardiac CryoAblation System features the new EvenCool™ Cryo Technology, which optimizes the delivery of coolant inside the balloon. As a result, the larger, more uniform cold surface reduces the effort needed to isolate the pulmonary veins, the target of most AF ablation procedures, and improves physicians'' ability to treat patients with complicated anatomies, compared to the first generation Arctic Front Cardiac CryoAblation System.

"The Arctic Front Advance Cardiac CryoAblation System will allow us to treat patients quickly, safely and effectively," said Dr. Marc Dubuc, Cardiologist and Electrophysiologist at the Montreal Heart Institute and Associate Professor at the Faculty of Medicine, University of Montreal.

Medtronic''s Cryoballoon treatment involves a minimally invasive procedure that isolates the pulmonary vein, a source of erratic electrical signals that cause AF, using coolant rather than heat (radiofrequency, or RF, ablation). Delivered via a catheter, Cryoballoon technology is associated with faster procedure times versus point-by-point, ablation. Additionally, 73 per cent of Medtronic cryoablation patients achieved freedom from AF at one year1,2, a clinically significant increase in success over AF drug therapy 1,2.

Cryoablation for cardiac ablation was pioneered at the Montreal Heart Institute, and Montreal-based CryoCath Technologies. The first-generation Arctic Front Cardiac CryoAblation Catheter System, currently approved in Canada, Europe and the United States, is the world''s leading Cryoballoon system indicated for the treatment of PAF. Since its introduction onto the market, it has been used to treat approximately 35,000 patients in more than 400 medical centres in 25 countries.

"In Canada, patients suffering from atrial fibrillation who might benefit from ablation therapy sometimes are faced with wait times in excess of one year to receive ablation therapy. The Arctic Front Advance Cardiac Cryoballoon System by Medtronic enables physicians to have the ability to treat more patients, potentially decreasing wait times and improving patient access, to proven, safe and effective solutions for PAF," said Neil Fraser, President of Medtronic of Canada.

About the Arctic Front Advance CryoAblation System

The Arctic Front Advance Cardiac Cryoballoon System is designed to be used with fluoroscopy and does not require the use of complex, three-dimensional mapping systems. The technologies currently offered in the system 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® 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.

About Atrial Fibrillation in Canada3

Approximately 300,000 Canadians are estimated to have atrial fibrillation, which is the most common type of arrhythmia. Atrial fibrillation accounts for 49 per cent of arrhythmia-related hospital stays and more days in the hospital than all other arrhythmias combined.

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 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.

About Medtronic of Canada

Medtronic of Canada Ltd. ( is a trusted Canadian leader delivering innovative health system solutions and advanced medical technologies to alleviate pain, restore health, and extend life in the areas of cardiovascular medicine, diabetes, spinal and neurosurgery, and ear, nose, throat surgery. Medtronic is proud to employ more than 745 Canadians. Headquartered in Brampton, Ontario, Medtronic has regional offices in Vancouver and Montreal, including a manufacturing facility, Medtronic CryoCath, located in Pointe-Claire, Quebec.

About Medtronic

Medtronic, Inc. ( headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

1 Andrade JG, Khairy P, Guerra PG, et al. Efficacy and safety of Cryoballoon ablation for atrial fibrillation: a systematic review of published studies. Heart Rhythm. September 2011;8(9):1444-1451.

2 Calkins H, Reynolds MR, Spector P, et al. Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. August 2009;2(4):349-361. on August 13, 2012.

3Humphries K et al. Can J Cardiol Vol 20 No 9 July 2004

Source: Medtronic

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