New Studies Support CardioFocus HeartLight(TM) Endoscopic Ablation System's Notable Treatment Results for Paroxysmal Atrial Fibrillation

MARLBOROUGH, Massachusetts, May 9, 2011 /PRNewswire/ -- -- Data Presented at Heart Rhythm 2011 Show Durable Pulmonary Vein Isolation of 86% --

CardioFocus, Inc., developer of the HeartLight Endoscopic Ablation System for the transcatheter treatment of Atrial Fibrillation (AF), announced its technology enables a Pulmonary Vein (PV) acute isolation rate of nearly 99%, with approximately 86% of PVs remaining persistently isolated after three months. Additional research also suggests that 65% of patients achieve durable freedom from AF after a single procedure.

New clinical results supporting the safety and efficacy of the HeartLight System were presented at Heart Rhythm 2011, the Heart Rhythm Society's 32nd Annual Scientific Sessions, in San Francisco, CA. The presentations included data from both a 200-patient international, multicenter clinical experience with the CardioFocus device (15 sites across four countries) and from a unique study that employed intracardiac diagnostic remapping on 56 paroxysmal AF patients, whether or not they were symptomatic, to determine the rate of persistent PV isolation.

"These recent clinical experiences support the promise of the HeartLight technology to help patients achieve lasting freedom from paroxysmal AF," commented Stephen Sagon, President and CEO of CardioFocus, Inc. "As shown by the robust data across multiple clinical centers, our proprietary technology, including endoscopic visualization, a compliant balloon catheter and the delivery of light energy, is helping to enhance the reproducibility and efficacy of atrial fibrillation ablation."

In the 200-patient study, titled "Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon: The First 200-Patient Multicenter Clinical Experience" and presented on May 6th, researchers reported nearly 99% of all PVs were isolated following the HeartLight ablation procedure. Of the 107 patients that reached at least 6 months follow-up, 65% remained free from AF after a single ablation procedure. The procedure also demonstrated low complication rates including freedom from strokes, PV stenosis or atrial esophageal fistulae.

"A historical concern with catheter ablation therapy for paroxysmal AF is the inability to create durable lesions in a single procedure to adequately isolate the pulmonary veins," said investigator Prof. Karl-Heinz Kuck, MD, of Krankenhaus St. Georg, Hamburg, Germany. "This study demonstrates that a higher-than-average rate of PV isolation can be reproducibly achieved across multiple sites with a visually-guided laser balloon catheter."

The remapping study, presented on May 4th and titled "Persistent Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon: Results of a Multicenter PV Remapping Study," revealed that 86% of all PVs were persistently isolated at three months. The study included 56 paroxysmal AF patients who underwent initial ablation with the HeartLight catheter at three centers. After three months nearly all patients were remapped (52), regardless of symptoms, to determine the incidence of persistent PV isolation.

"This data is significant because diagnostic remapping to check PV isolation in asymptomatic patients is rarely attempted. In this case it has enabled us to clearly confirm quality outcomes, demonstrating that the visually-guided laser balloon catheter can achieve persistent, long-lasting PV isolation in patients with paroxysmal AF," said investigator Petr Neuzil, MD, of Na Homolce Hospital, Prague, Czech Republic.

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(TM) Ablation System incorporates a catheter containing both a micro-endoscope and light energy fibers to give physicians 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 received CE Mark in 2009 for the treatment of atrial fibrillation, and is commercially available at key institutions throughout Europe. The device is investigational in the U.S., with a pivotal study expected to commence in 2011. CardioFocus is headquartered in Marlborough, MA. For more information on the company and its technology, please visit http://www.CardioFocus.com.

The scientific information discussed in this news release is preliminary and investigative. The CardioFocus 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.

    
    Company Contact:               Media Contact:
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    Anjie Roldan                   Lisa Cook/Jason Rando
    Vice President Finance         +1-646-536-7012/7025
    +1-508-658-7237                lcook@theruthgroup.com
    aroldan@cardiofocus.com        jrando@theruthgroup.com