Medtronic, Inc. 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 Canadians[1] 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, MD, 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.”

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.

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.

[1] http://www.heartandstroke.on.ca/site/c.pvI3IeNWJwE/b.5052981/k.2CA6/Hear...
[2] Millenium Research Report; “Global Markets For Atrial Fibrillation Treatment Devices 2008,” March 2008; 1.
[3] Go AS, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001;285:2370-5.
[4] Fuster V, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol 2006;48:854-906.