Mayo Clinic has used the US Food and Drug Administration (FDA) approved minimally invasive freezing balloon technology in the US, for the treatment of atrial fibrillation (AF).
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.