MARLBOROUGH, Mass., Oct. 15, 2013 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), today announced that it has concluded enrollment of its U.S. pivotal trial evaluating the HeartLight system, for the treatment of symptomatic paroxysmal AF.
The randomized, controlled trial completed enrollment of over 400 patients from 21 leading research sites across the United States. The two-arm study investigated the use of the endoscopically guided HeartLight catheter in comparison to ordinary radiofrequency ablation using the NaviStar® THERMOCOOL® Catheter (Biosense Webster). A single ablation procedure was conducted in the HeartLight arm, while a repeat ablation was permitted with the THERMOCOOL system.
The primary endpoints include an assessment of safety and an evaluation of efficacy, which is defined as freedom from documented, symptomatic AF at one year. With these findings, CardioFocus plans to submit a Premarket Approval (PMA) filing with the U.S. Food and Drug Administration (FDA) for HeartLight EAS following the completion of follow-up. The HeartLight system is CE marked and is commercially available for this indication in the European Union and Australia.
The HeartLight EAS is the first catheter ablation system to incorporate an endoscope for direct visualization of the cardiac anatomy in a beating heart, in real time and without radiation. It includes a compliant balloon catheter designed for improved contact with the pulmonary vein ostium (opening) irrespective of individual patient anatomy, and a laser energy source designed for more efficient, precise and durable ablation therapy.
Vivek Y. Reddy, MD, Co-Principal Investigator and Professor of Medicine at the Mount Sinai School of Medicine, one of the top centers in patient enrollment for the trial, said, "The HeartLight laser balloon system holds considerable promise for durable pulmonary vein isolation. With the potential FDA approval, the HeartLight would become a unique and valuable addition to the existing arsenal in the fight against atrial fibrillation."
"Atrial fibrillation is the most common arrhythmia diagnosed, as well as the most frustrating to treat," said Andrea Natale, MD, Co-Principal Investigator and Executive Medical Director of Texas Cardiac Arrhythmia at St. David's Medical Center. "While pulmonary vein isolation has the ability to effectively treat AF, many traditional catheter ablation devices are unsuccessful at achieving durable, gapless ablation due to their design limitations. However, the combined endoscope, balloon and laser in the HeartLight system could have the potential to improve the current standard of care for treating this complex condition."
Burke Barrett, Study Director and Vice President of Regulatory and Clinical Affairs at CardioFocus, said, "Completion of enrollment in this pivotal study is a significant milestone for CardioFocus and our technology, and we anticipate having results ready for submission to the FDA shortly after the one year follow-up period. Our sincere thanks to the prominent investigators and medical centers involved in the trial for completing the enrollment phase of the study on time, while focusing on conducting a high-quality study."
"Physicians across Europe and Australia have rapidly adopted the HeartLight system over the past year, recognizing that direct visualization and precise ablation combines to provide an impressive success rate," said Stephen Sagon, President of CardioFocus. "As a result, physicians and their patients are more justified in expecting freedom from AF after a single ablation procedure. We look forward to satisfying the large and still unmet need for single procedure efficacy in the U.S."
For more information on the trial, please visit http://clinicaltrials.gov/show/NCT01456000.
To learn about the Company and its HeartLight technology, please visit www.CardioFocus.com.
About CardioFocus, Inc.
CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). 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.
The HeartLight Endoscopic Ablation System is commercially available at leading institutions throughout Europe and in Australia. The device is investigational in the U.S., and currently the focus of a pivotal trial initiated in 2012. 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.
SOURCE CardioFocus, Inc.