Mayo Clinic was the trial site for STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation), which led to FDA approval.
The 26-site study involving 245 patients showed that 69.9% of patients treated with the balloon technology were free from AF at one year, compared with 7.3% patients treated only with drug therapy, another method for treating AF.
The technology is used to treat drug refractory recurrent symptomatic paroxysmal AF, a type of AF in which irregular heartbeats in the upper chambers of the heart start and stop suddenly on their own.
The new system uses a balloon-based technology delivered through a catheter with a coolant rather than heat to create circumferential lesions around the pulmonary vein to block the conduction of AF in cardiac tissues.
