Medtronic announces new data from STOP AF pivotal trial

May 14, 2010

MINNEAPOLIS and DENVER – May 14, 2010 – Medtronic today released new STOP AF (sustained treatment of paroxysmal atrial fibrillation) clinical trial data showing the number of paroxysmal atrial fibrillation (AF) patients reporting AF symptoms declined by 80 percent after treatment with the Arctic Front Cardiac CryoAblation Catheter System. Additionally, as reported in the quality-of-life questionnaire (SF-36) results, all patients randomized and treated with the Arctic Front Cardiac CryoAblation Catheter System reported significant improvements in physical and mental quality-of-life factors when compared to baseline measurements (P<0.001). This data was presented as a late-breaking clinical trial at Heart Rhythm 2010, the Heart Rhythm Society’s 31st Annual Scientific Sessions. The CryoAblation System is commercially available for use in Europe; it is under investigational use in the United States. The number of patients randomized to cryoablation in the STOP AF trial who reported AF symptoms declined from 100 percent at baseline (pre-treatment) to 20 percent at 12 months after cryoablation treatment. Specifically, when compared at baseline and 12 months, there was a reduction in the number of study participants who reported the following six symptom categories: palpitations (86 to 25 percent), fatigue (76 to 13 percent), rapid heart beat (66 to 16 percent), dyspnea, or difficulty breathing (54 to 9 percent), dizziness (48 to 9 percent), and syncope, or fainting (4 to 1 percent). To some AF patients, these symptoms can be debilitating.

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