The approval was based on the pivotal sustained treatment of paroxysmal atrial fibrillation (STOP AF) trial, which demonstrated the safety and efficacy of the device in treating and eradicating paroxysmal atrial fibrillation.
Medtronic said 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.
Cryoballoon-based technology 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 catheter stability.
Medtronic of Canada president Neil Fraser said the system was designed, developed and manufactured in Canada with a global mandate, including supplying the US and Europe.
"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," Fraser said.
Medtronic acquired Montreal-based CryoCath Technologies and US based Ablation Frontiers 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.
