Medtronic’s (MDT) newest device used to treat a condition where the heart sometimes beats irregularly was granted approval by federal regulators on Friday.
The Minneapolis-based medical device maker said its Arctic Front Advance Cardiac Cryoballoon will be used in a minimally invasive procedure to treat paroxysmal atrial fibrillation.
The device features new EvenCool Cryo technology, which dispatches coolant inside of the balloon. The larger, more uniform cold surface of the balloon reduces the effort needed to isolate the pulmonary veins, the target of most AF ablation procedures, Medtronic said.
“We are now able to more effectively treat a broader range of pulmonary vein anatomies with less effort, which can potentially reduce procedure times," said Dr. Vivek Reddy, director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York.
Using a coolant rather than heat with the procedure, known as radiofrequency ablation, the technology, which is delivered via a catheter, has been associated with faster procedures times versus the point-by-point of RF ablation.
Medtronic said 73% of patients in a study for this device were free of atrial fibrillation at year one, a “clinically significant increase in success” over the placebo.