Multicenter European Study to Evaluate CardioFocus HeartLight® System for Persistent Atrial Fibrillation

-- First to Prospectively Assess Outcomes of Pulmonary Vein Isolation with Balloon Ablation Catheters in Persistent AF Population

MARLBOROUGH, Massachusetts, June 25, 2013 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), announces that its HeartLight technology is the focus of a multicenter European clinical study for the treatment of drug-refractory persistent AF. The study, taking place at five centers in Germany and the Czech Republic, will be the first to prospectively assess pulmonary vein isolation (PVI) with balloon ablation catheters in a persistent AF patient population. The first three patients were enrolled this month at Cardioangiologisches Centrum Bethanien (CCB) in Frankfurt, Germany.

Boris Schmidt, MD, of CCB and Principal Investigator of the trial, said, "The HeartLight System has been used with notable clinical success in the treatment of paroxysmal AF, with multicenter remapping studies demonstrating more durable pulmonary vein isolation than achieved with alternative catheter systems. Previous research with radiofrequency ablation technology also suggests that PVI may also be an effective initial treatment for persistent AF, but due to high rates of reconnection, patients often require more than one intervention. With this study, we hope to establish initial data around the use of balloon catheters for this clinical application and lay the groundwork for further study of HeartLight in advanced AF treatment."

The prospective trial will enroll and randomize 150 patients with drug-refractory persistent AF (episode duration of >7 days and <1 year) to receive catheter ablation with either HeartLight or a commercial irrigated radiofrequency (RF) catheter and electroanatomical mapping. The aim of the study is to assess the safety and efficacy of PVI using HeartLight in comparison to RF ablation, as the role of balloon catheters in the treatment of persistent AF remains undefined. The trial is expected to complete enrollment by May 2014 and will follow patients for one year post procedure.

Stephen Sagon, President of CardioFocus, said, "We are excited that our technology will be used in this groundbreaking study. European clinical experience to date has confirmed the clinical advantages of HeartLight's direct visualization capabilities and unique laser energy source; this new study will assess the value of achieving durable PVI in this challenging-to-treat population."

HeartLight is the first catheter ablation system to incorporate an endoscope for direct visualization of the pulmonary veins. It includes a compliant balloon catheter designed for improved contact with the PV ostium (opening) irrespective of individual patient anatomy, and a laser energy source for more efficient and precise ablation.

The HeartLight technique is a widely used index procedure for the treatment of paroxysmal AF at centers throughout Europe, where data has demonstrated an 83% single procedure chronic success rate with the technology.  HeartLight is also the focus of an ongoing pivotal trial in the U.S., which is nearing the conclusion of the enrollment phase. For more information, visit www.aftrial.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.