Medtronic Receives Health Canada Approval for The Newest Radiofrequency Ablation Tools for Atrial Fibrillation
Medtronic Ablation Frontiers Cardiac Ablation System Delivers Treatment for the Most Common Heart Arrhythmia
MINNEAPOLIS and BRAMPTON, ONTARIO - Medtronic, Inc. (NYSE: MDT) today announced it received Health Canada approval for the Medtronic Ablation Frontiers Cardiac Ablation System, a novel radiofrequency (RF) ablation technology for the treatment of atrial fibrillation (AF). AF is the most common heart arrhythmia that affects more than 250,000 Canadians1 and seven million people worldwide.2
The Medtronic Ablation Frontiers Cardiac Ablation System tools now approved for use in Canada include the GENius™ Multi-Channel Radiofrequency Generator and the Pulmonary Vein Ablation Catheter (PVAC)™, a single anatomically shaped mapping and ablation catheter designed to efficiently isolate the pulmonary veins to treat AF. The GENius generator and PVAC, with the addition of the Multi-Array Septal Catheter (MASC)™ and Multi-Array Ablation Catheter (MAAC)™, are available in Europe and are under investigational use in the United States. Medtronic will provide periodic clinical updates on the safety and effectiveness of the PVAC catheter as a condition of Health Canada’s approval.
“This three-dimensional RF catheter is an improvement from the currently used focal system; it simplifies the AF ablation procedure allowing me to better predict my procedure times and therefore, treat more patients in one day,” said Yaariv Khaykin, M.D., electrophysiologist at the Southlake Regional Health Centre in Newmarket, Ontario, who was the first to use the new technology in Canada. “This novel technology also gives me the flexibility to tailor ablation therapy for specific patient needs and different anatomies.”
Catheter ablation is a common interventional treatment for many types of cardiac arrhythmias. When used to treat AF, RF catheter ablation is a minimally invasive procedure designed to stop the rapid beating of the atria by isolating and blocking the triggers and conduction pathways that can initiate AF. In Canada, AF ablation procedures traditionally use a point-by-point focal ablation technique involving multiple catheters. Medtronic’s novel three-dimensional catheter allows physicians to target a broader area and efficiently map, pace, ablate and confirm isolation of the pulmonary veins, with a single catheter.
“As one of the newest tools in Medtronic’s rapidly growing AF Solutions portfolio, our aim is to provide physicians with easy-to-use ablation technologies that help them safely treat those suffering from AF, when used as indicated,” said Reggie Groves, vice president and general manager of Medtronic’s AF Solutions division.
Medtronic acquired U.S.-based Ablation Frontiers, Inc., and Montreal-based CryoCath Technologies, Inc. to form Medtronic’s AF Solutions division. 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.
Note: The Medtronic Ablation Frontiers Cardiac Ablation System is investigational and not currently available for sale in the United States. The device is limited by federal law to investigational use only.
About Atrial Fibrillation
Atrial fibrillation is an irregular quivering or rapid heart rhythm in the upper chambers (atria) of the heart, which causes inefficient pumping of the heart and can lead to other rhythm problems as well as chronic fatigue, difficulty breathing and heart failure. Half of all diagnosed AF patients fail drug therapy.3 If left untreated, AF patients have a five times higher risk of stroke.4
Medtronic, Inc. (www.medtronic.com), 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.
2 Millenium Research Report; “Global Markets For Atrial Fibrillation Treatment Devices 2008,” March 2008; 1.
3JAMA 2001; 285:2370-5.
4Fuster et al. Journal of the American College of Cardiology. 2006; 48:854-906.
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