Medtronic has received the US Food and Drug Administration (FDA) approval for its Arctic Front Cardiac CryoAblation Catheter system, the Cryoballoon indicated for the treatment of drug refractory paroxysmal atrial fibrillation (PAF).
Medtronic said the Cryoballoon treatment involves a minimally-invasive procedure that efficiently creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.
The FDA approval of the Arctic Front System was based on the pivotal STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial, which demonstrated the safety and efficacy of the device in treating and eradicating paroxysmal atrial fibrillation.
Balloon-based technology ablates or blocks the conduction of atrial fibrillation (AF) in cardiac tissue through the use of a coolant rather than heat, which is delivered through a catheter.
The freezing technology allows the catheter to adhere to the tissue during ablation, allowing for greater catheter stability.
The Mount Sinai Medical Center in New York Electrophysiology Laboratories director Vivek Reddy said the technology represents a significant improvement over currently used focal ablation treatment for atrial fibrillation.
"This ablation approach fills an unmet need in AF ablation by providing a straightforward and efficient approach to pulmonary vein isolation, while giving patients a new, minimally-invasive treatment approach proven to be safe and effective," Reddy said.