CardioFocus Inc. HeartLight® U.S. Pivotal Trial is on Track for Full Enrollment in 2013
Published: Jan 14, 2013
MARLBOROUGH, Mass., Jan. 14, 2013 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), announces the U.S. pivotal trial evaluating the safety and efficacy of the HeartLight system is approximately half enrolled. The study, initiated in 2012, is on track to complete enrollment this year. HeartLight is the first catheter ablation system to incorporate an endoscope for direct visualization of the beating heart, a laser energy source and a compliant balloon catheter.
Burke Barrett, Vice President of Regulatory & Clinical Affairs at CardioFocus, said, "Achieving this enrollment milestone speaks to the clinical need for an advanced treatment for AF, a condition that is only continuing to increase in prevalence. We are excited that so many prominent physicians across the country have joined the trial as investigators and believe in the promise of the technology for their patients. We're on track to conclude enrollment in 2013 and, after the one year follow-up period, will prepare the data for submission to the FDA."
In the U.S., approximately three million people suffer with AF, the most common cardiac arrhythmia. The HeartLight pivotal trial is randomizing the HeartLight system against the THERMOCOOL® Catheter (Biosense Webster), and will randomize an estimated 350 patients in this multi-center U.S. trial. Currently, over 180 patients have been enrolled at 21 sites; the Company expects to complete enrollment this year. The HeartLight system is CE marked and clinically available in Europe and Australia.
Vivek Y. Reddy, MD, of Mt. Sinai University Medical Center, New York, NY and co-principal investigator of the trial, said, "A key challenge in the treatment of AF has been the durability of the intervention, as historically, a large number of patients who undergo catheter ablation experience a recurrence of the arrhythmia within a year. In this trial, we are investigating whether the unique attributes of the HeartLight technology can impact both acute and chronic freedom from AF, and offer a new option for treating this complex condition."
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.
Vice President Finance
SOURCE CardioFocus, Inc.