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New CardioFocus Inc. HeartLight$0174 Data Reinforces Impressive Single Procedure Chronic Success Rates in the Treatment of Atrial Fibrillation



9/7/2012 10:19:59 AM

MARLBOROUGH, Mass., Sept. 6, 2012 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces new data showing pulmonary vein isolation (PVI) with its technology leads to a 99% acute success rate and up to an 82% chronic success rate at 12 months follow-up. In addition, the research indicates the HeartLight laser balloon technology resulted in improved long-term outcomes after a single procedure as compared with the cryothermal balloon catheter. The data was presented on Sunday, August 26 at the European Society of Cardiology (ESC) Congress 2012, in Munich, Germany.

Stephen Sagon, President and CEO of CardioFocus, said, "The presented outcomes data with the HeartLight system are particularly impressive because high chronic success rates have been elusive, let alone from a single procedure. We are encouraged by the continued performance of our system and its positive impact on patient care, especially as compared with alternative ablation technologies. As physicians hone their technique with endoscopically guided ablation, we anticipate further studies reinforcing these durable success rates."

In the presented study titled, "Laser or Cryo? Prospective comparison of balloon based PVI technologies," researchers from Cardioangiologisches Centrum Bethanien (CCB), Frankfurt, Germany allocated 140 patients 1:1 to undergo catheter ablation with the HeartLight laser balloon or the cryothermal balloon (Medtronic Arctic Front®). Acute isolation rates were comparable (98.9% vs. 99.6%, respectively). However, during 12-months follow-up, 37% of patients treated with the cryoballoon experienced AF recurrence vs. only 27% treated with a single HeartLight system procedure.

After repeat procedures with radiofrequency ablation as needed, both technologies demonstrated a chronic success rate of approximately 80%, though notably, the number of redo procedures was twice as high with the cryothermal balloon vs. HeartLight (22 vs. 11). Analysis of the veins themselves also demonstrated a 37% relative risk reduction of PV reconnection using the HeartLight technique.

"We were interested in prospectively evaluating the outcomes achievable with HeartLight compared to the established cryothermal balloon catheter," said Boris Schmidt, MD, of CCB. "While we found the systems to have comparable safety and acute efficacy outcomes, the HeartLight system, in fact, led to a higher rate of longer-term freedom from AF after a single procedure. We look forward to further, multicenter study on this comparison."

In the second presentation, titled "Pulmonary vein isolation for paroxysmal atrial fibrillation with the laser balloon," researchers at Na Homolce Hospital in Prague, Czech Republic, highlighted outcomes of three years (2009-2011) of HeartLight cases at their center. They found that at a mean 12 months follow-up, 82% of patients remained free from AF. In addition, acute PVI was documented at 100% for all of 2011, supporting the short learning curve and high reproducibility of the procedure.

"These data are a testament to our positive experiences with the HeartLight Endoscopic Ablation System since its incorporation into our practice over three years ago," said Prof. Petr Neuzil, MD, of Na Homolce Hospital. "Our research demonstrates the laser balloon PV isolation procedure to be safe, with acute results comparable to those of radiofrequency ablation procedures and longer-term results showing a compelling degree of continued isolation."

In addition, these recently available clinical results were the focus of an academic symposium on the evening of Monday, August 27. Cardiologists from across Europe and the U.S. discussed their experiences with the system for PVI and its potential to improve the safety and efficacy in AF ablation.

CardioFocus will also be participating in the 9th International Symposium on Catheter Ablation Techniques (ISCAT) in Paris, France later this month. For more information on the Company or the 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.

Company Contact:

Media Contact:

Anjie Roldan

Lisa Cook

Vice President Finance

(646) 536-7012

(508) 658-7237

lcook@theruthgroup.com

aroldan@cardiofocus.com


SOURCE CardioFocus, Inc.


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