CardioFocus, a privately held medical device company based in Marlborough, Massachusetts, is a manufacturer of disposable fiber optic catheters.
CardioFocus, a privately held medical device company based in Marlborough, Massachusetts, is a manufacturer of disposable fiber optic catheters for the visualization of the cardiac anatomy and the treatment of cardiac arrhythmias such as atrial fibrillation (AFib). AFib is the most common cardiac arrhythmia, affecting approximately 2.3 million people in the U.S. and 4.5 million people in the developed world. AFib is one of the most underserved cardiology markets today.
CardioFocus’ HeartLight™ Endoscopic Ablation System for catheter ablation incorporates an endoscope to provide physicians with the capacity to see within the heart and visually direct the application of laser energy to achieve durable pulmonary vein isolation, the cornerstone of AFib treatment. CardioFocus recently presented new data showing pulmonary vein isolation with their technology leads to a 99% acute success rate and up to an 82% chronic success rate at 12 months follow-up. The system received a CE Mark in 2009 for the treatment of atrial fibrillation and is commercially available throughout Europe and in Australia. A pivotal trial for U.S. approval was initiated in 2012.