First Patient Treated in CardioFocus Inc. HeartLight EAS Pivotal Trial
Published: Feb 21, 2012
MARLBOROUGH, Mass., Feb. 21, 2012 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces the first patient has been enrolled and treated in the HeartLight EAS U.S. pivotal trial, designed to evaluate the safety and efficacy of the technology in treating symptomatic AF. The 48-year-old patient, one of the nearly three million Americans with AF,[i] had suffered with paroxysmal AF for three years and underwent successful pulmonary vein (PV) isolation at Mount Sinai School of Medicine in New York, NY. All four PVs were isolated on the very first attempt using only visual guidance during the approximately two hour procedure.
The HeartLight EAS is the first catheter ablation system to incorporate an endoscope for direct visualization of a beating heart, in real time and without radiation. It includes a compliant, dynamically adjustable balloon catheter designed for improved contact with the PV ostium (opening) irrespective of individual patient anatomy, and utilizes laser energy for more efficient, durable and precise ablation. The Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval for HeartLight EAS in December 2011, enabling the initiation of the trial.
"The visually-guided HeartLight EAS is unique in cardiac catheter ablation and offers a promising new treatment option for drug-refractory atrial fibrillation. For the first time, physicians can see within a beating heart to more precisely deliver ablation energy and confirm contiguous lesion placement, which we believe may lead to improved patient outcomes," said Vivek Y. Reddy, MD, of Mount Sinai School of Medicine, and Principal Investigator of the trial. "The system has been used with great clinical success in Europe, with recent published data supporting the high rate of both acute and durable PV isolation enabled by the device. We are optimistic that we will be able to achieve similar results in this trial."
The prospective trial will randomize the HeartLight EAS against the NaviStar® THERMOCOOL® Catheter (Biosense Webster). Only a single ablation procedure with the HeartLight EAS will be permitted, while repeat ablation may be performed with the THERMOCOOL system. In total, the trial will randomize an estimated 350 patients at up to 25 sites in the U.S. and follow them for one year post procedure.
The primary outcome measures will assess both safety and freedom from documented, symptomatic atrial fibrillation. The results will be used as the basis for CardioFocus's Premarket Approval (PMA) filing with the FDA for HeartLight EAS. In addition to Mount Sinai, Texas Cardiac Arrhythmia Research Foundation in Austin, TX is also currently enrolling patients.
"Catheter ablation offers a minimally invasive, interventional treatment option for millions of people with drug-refractory AF. However, traditional systems have demonstrated limited durable pulmonary vein isolation and compromised long-term efficacy after only a single procedure," said Andrea Natale, MD, of Texas Cardiac Arrhythmia Research Foundation and trial Co-Principal Investigator. "We are excited to be involved in evaluating this ground-breaking catheter ablation option that has the potential to improve upon the current standard of care."
"Beginning this pivotal trial is a key milestone for CardioFocus and our technology, as it brings us one step closer to offering the HeartLight EAS treatment option to patients in the U.S.," said Stephen Sagon, President and CEO of CardioFocus. "We look forward to working with the prominent medical centers involved in this trial, and expect their experiences to demonstrate the clinical advantages of the HeartLight EAS' visualization capabilities, compliant balloon and unique energy source."
The HeartLight EAS technology is currently available at sites throughout Europe for the treatment of AF. For more information on the trial, please visit http://clinicaltrials.gov/show/NCT01456000.
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. 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.
[i] Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart Disease and Stroke Statistics2010 Update: a report from the American Heart Association. Circulation. 2010;121:e91, via CDC "Atrial Fibrillation Fact Sheet."
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SOURCE CardioFocus, Inc.