Wednesday, January 05, 2011
ROCHESTER, Minn. — Mayo Clinic is the first in the U.S. to use the first minimally invasive freezing balloon technology for the treatment of atrial fibrillation (AF) approved in December by the U.S. Food and Drug Administration. The first patient received the treatment Tuesday, Jan. 4.
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. "This approach provides a single ablative means of eliminating problematic AF in patients who failed drug therapy," says Douglas Packer, M.D., Mayo Clinic cardiologist.
Mayo Clinic was a 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 percent of patients treated with the balloon technology were free from AF at one year, compared with 7.3 percent of patients treated only with drug therapy, another method for treating AF. Dr. Packer was principal investigator of the clinical trial. "It is critical that these devices go through rigorous clinical trial testing to prove benefit and safety before they are approved," he says.
Atrial fibrillation is the most common cardiac arrhythmia seen by physicians and affects more than 2 million Americans. Most individuals with atrial fibrillation have identifiable risk factors, such as high blood pressure or structural heart disease, and tend to be elderly. Long-term complications resulting from atrial fibrillation and its treatment can include death, disabling stroke, serious bleeding and/or cardiac arrest.
The new technology, the Arctic Front Cardiac CryoAblation Catheter system, is manufactured by Medtronic, based in Minneapolis.
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