AFib is associated with a five-fold increased risk for stroke and an increased risk for congestive heart failure, left ventricular dysfunction, and cardiovascular hospitalizations; and a two-fold increase in mortality.
AFib often feels like a fluttering or "butterflies" in the chest. Some people with AFib have no symptoms at all.
Successful outcomes with CircumBlator will improve quality of life for individuals with AFib and significantly reduce costs associated with treatment.
Special cells in the heart create electrical signals that travel along pathways to the chambers of the heart. These signals make the heart’s upper and lower chambers beat in the proper sequence. Abnormal cells may create disorganized electrical signals that cause irregular or rapid heartbeats called arrhythmias. The most common irregular heartbeat, and potentially deadly disorder, is called atrial fibrillation or AFib.
AFib is associated with other diseases such as myocardial infarction, heart valve disease, hypertension, infection, and sleep apnea. Patients with AFib can have palpitations, chest discomfort, weakness, fainting, breathlessness, fatigue and sometimes no symptoms at all. The burden of AFib can significantly affect the quality of life for patients by limiting their ability to work and play.
It is estimated that 30 million individuals worldwide have been diagnosed with AFib, and annually more than 300,000 receive an ablation procedure to block these electrical impulses. Of those, many will need to have multiple ablation procedures. The total cost of treating AFib was $24 billion in the U.S. in 2014.
The CircumBlator™ AF Catheter Ablation System is not approved for human use.