-- 12-month Clinical Trial Met Primary Safety and Efficacy Endpoints
MARLBOROUGH, Massachusetts, May 15, 2015 /PRNewswire/ -- 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.
Dr. Reddy commented, "These results demonstrate that a group of physicians largely new to the HeartLight® technique can equal their performance with the control arm device by using the HeartLight® System. Importantly, these results were obtained early in the HeartLight® learning curve from veteran radiofrequency (RF) catheter ablation practitioners with extensive experience with the control arm device."
Andrea Natale MD, FACC, FHRS, FESC, Co-Principal Investigator of the HeartLight® U.S. Pivotal Trial and Executive Medical Director at the Texas Cardiac Arrhythmia Institute at St. David's Medical Center, added, "In addition to the impressive findings, more than 90 percent of the study investigators had no substantial prior experience in the clinical usage of the HeartLight® catheter. An exploratory analysis showed that physicians performing 15 or more HeartLight® ablation procedures achieved a higher success rate and fewer primary adverse events with the HeartLight® device."
Burke T. Barrett, CardioFocus' VP of Regulatory & Clinical Affairs, said, "We are grateful to each clinical investigator across the 21 trial sites for their commitment and focus to evaluate the HeartLight® Endoscopic Ablation System with the thoroughness and rigor they demonstrated. We look forward to responding to the FDA during the upcoming application review process."
The company plans to submit the pivotal clinical study results to the U.S. Food and Drug Administration (FDA) in the near future as part of an ongoing modular PMA process. It is important to note that because the results of the HeartLight® study have not yet been submitted to the FDA for an independent review they are considered preliminary.
These data from the 21-center randomized HeartLight® U.S. Pivotal Trial add to the large body of clinical evidence encompassing nearly two dozen independent studies conducted over the last several years in the European Union supporting the CardioFocus HeartLight® Endoscopic Ablation System. Recently, at the German Cardiology Society (DGK) meeting, these results were confirmed by several single-center reports of high rates of freedom from AF recurrence measured one year after the performance of a single ablation procedure using the CardioFocus endoscopically guided laser catheter. To date, more than 2,800 patients worldwide have had their AF successfully treated using the CardioFocus HeartLight® System.
Stephen Sagon, President of CardioFocus, commented, "This has truly been a tremendous effort from everyone involved including our dedicated employees and esteemed clinical investigators. As the developers of a completely new technique to treat atrial fibrillation, it is a significant honor to have our data presented as a late-breaking clinical trial to the greater community of arrhythmia specialists. We look forward to continuing our favorable progress for this potentially important treatment for atrial fibrillation."
The HeartLight® Endoscopic Ablation System is designed to provide physicians with a practical, easy-to-use treatment for AF with the ability to see within their patient's heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.
To learn about the Company and its HeartLight® technology, please visit www.CardioFocus.com.
About the HeartLight® Endoscopic Ablation System
The HeartLight® Endoscopic Ablation System is a unique catheter ablation technology for the treatment of atrial fibrillation (AF), the most common heart arrhythmia. Its novel HeartLight® Endoscopic Ablation System for catheter ablation incorporates an endoscope to provide physicians with the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.
About Heart Rhythm 2015
Heart Rhythm 2015 is the most comprehensive educational program for heart rhythm professionals, featuring more than 250 educational sessions and more than 130 exhibitors showcasing innovative products and services. The Heart Rhythm Society's Annual Scientific Sessions have become the must-attend event of the year, allowing the exchange of new vital ideas and information among colleagues from every corner of the globe.
About CardioFocus, Inc.
CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). The HeartLight® Endoscopic Ablation System is commercially available at leading institutions throughout Europe. CardioFocus is headquartered in Marlborough, MA, USA. For more information on the company and its technology, please visit www.CardioFocus.com.
The scientific information discussed in this news release is preliminary and investigative. The CardioFocus HeartLight® Endoscopic Ablation System is not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the system. Only FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.
The HeartLight® System is an investigational device in the U.S. The FDA has not had the opportunity to review the raw data, evaluate the adjudication of the safety and effectiveness assessments or conduct an independent confirmation of the analyses and endpoint calculations and so the results of the HeartLight® study are considered preliminary.
SOURCE CardioFocus, Inc.