Health Canada Approves RF Ablation System for Atrial Fibrillation

August 20, 2010 – Health Canada granted market approval for the Medtronic Ablation Frontiers Cardiac Ablation System, a radiofrequency (RF) ablation system to treat atrial fibrillation (AF).

The ablation 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.

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 electrophysiology (EP) systems product portfolio, AF Solutions offers an extensive line of diagnostic, cryoablation and radiofrequency ablation tools to diagnose and treat a broad spectrum of cardiac arrhythmias.

For more information: www.medtronic.com