HeartLightŪ Results Presented at Heart Rhythm 2015
MARLBOROUGH, Mass - CardioFocus, Inc., a medical device company developing the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), the most common cardiac arrhythmia affecting millions globally, today announced its U.S. Pivotal Trial data were presented by co-principal investigator Dr. Vivek Y. Reddy, Professor of Medicine at the Mount Sinai School of Medicine. Speaking today in Boston during the late-breaking clinical trial session at Heart Rhythm 2015, the preeminent arrhythmia meeting of the year, Dr. Reddy revealed that the trial, which randomized CardioFocus' HeartLight® Endoscopic Ablation System one-to-one versus the Biosense Webster Thermocool® catheter, met both primary efficacy and safety endpoints and demonstrated a low learning curve for physicians using the HeartLight® System.
Trial results show that when performing a single ablation procedure using the HeartLight® System, the majority of patients experienced freedom from paroxysmal AF at 12 months. Moreover, the primary safety endpoint and the primary efficacy endpoint of freedom from AF at 12 months were satisfied for the pre-specified non-inferiority test as per the study design.
The study protocol permitted investigators to perform only a single pulmonary vein isolation (PVI) procedure using HeartLight®. Investigators were able to use the control arm device for both PVI and other left atrial targets, with up to two control arm procedures allowed. Continue>
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