CardioFocus Trial Meets Primary Efficacy and Safety Endpoints

CardioFocus, Inc., a medical device company known for it flagship product, HeartLight® Endoscopic Ablation System, for patients suffering from atrial fibrillation, presented its U.S. Pivotal Trial data at the Heart Rhythm Conference in Boston last month. The trial’s co-principal investigator, Dr. Vivek Y. Reddy, Professor of Medicine at the Mount Sinai School of Medicine, presented the data. Dr. Reddy announced that the trial reached primary efficacy and safety endpoints, and demonstrated a low learning curve for physicians using the HeartLight System. CardioFocus will present the clinical study’s groundbreaking results to the U.S. Food and Drug Administration (FDA), in conjunction with a continuing modular PMA process.