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CAP-AF Clinical Trial CAP AFThe goal of the Continued Access Protocol for Atrial Fibrillation (CAP AF) clinical trial is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front CryoAblation System is under review. EuropeArctic Front® has received the European CE Mark for the treatment of paroxysmal Atrial Fibrillation. The CE Mark certification allows Medtronic CryoCath to market its system throughout the European Union. Arctic Front® has already treated more than 5000 patients in more than 100 centers across Europe. United StatesMedtronic CryoCath has now completed patient enrollment in the pivotal phase of the STOP AF trial for the treatment of paroxysmal atrial fibrillation being conducted under an Investigational Device Exemption (IDE). About Arctic Front®Arctic Front® is a minimally invasive cryo-balloon catheter designed specifically to treat Paroxysmal Atrial Fibrillation. It is used for the ablation of the pulmonary veins (pulmonary veins carry fresh blood and oxygen from the lungs to the left atrium of the heart). About Atrial FibrillationAF, described as a rapid and chaotic quivering of the top two chambers in the heart, is the most prevalent arrhythmia, affecting more than 15 million patients worldwide with an annual incidence of 1.1 million new cases per year. It is a leading cause of stroke and hospitalizations, and has become the most common complication of cardiovascular surgery. If left untreated, it can lead to heart failure and death. |
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