Medtronic has completed pre-market approval (PMA) submission in consideration for FDA approval for its Arctic Front Cardiac CryoAblation Catheter System, which is designed for patients with paroxysmal atrial fibrillation (PAF), an irregular quivering of the upper chambers of the heart that starts and stops on its own.
Medtronic said that PMA submission includes data from the STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) pivotal clinical trial which has been presented at the 59th Annual Scientific Session of the American College of Cardiology.
The data from the STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) clinical trial which showed superiority over antiarrhythmic drugs, with 69.9% of patients with paroxysmal atrial fibrillation (PAF) treated with the Arctic Front Cardiac CryoAblation Catheter System remaining free of atrial fibrillation (AF) one year after cryoablation, compared to 7.3% on drug therapy.
The clinical trial evaluated the safety and effectiveness of the Arctic Front Cryocatheter System compared to anti-arrhythmic drug therapy.
The Medtronic Arctic Front Cardiac CryoAblation Catheter System is designed to be used with fluoroscopy and does not require the use of complex, three-dimensional electroanatomical mapping systems. The Catheter System is investigational and not currently available for sale in the US. The device is limited by federal law to investigational use only.