Journal of Cardiovascular Electrophysiology Study Shows Promising Single Ablation Procedure Outcomes With HeartLight EAS for Treatment of Atrial Fibrillation Researchers Achieve 98% Acute Pulmonary Vein Isolation, with 77% of Patients in Sinus Rhythm at Approximately Nine Months Follow-up

MARLBOROUGH, Mass., Jan. 17, 2012 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight™ Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announces that a new study in the Journal of Cardiovascular Electrophysiology demonstrates the high acute and chronic success rates achievable with a single AF ablation procedure using HeartLight EAS. The study was conducted by Boris Schmidt, MD, and colleagues at Cardioangiologisches Centrum Bethanien, Frankfurt, Germany, and was published online in January 2012.

The HeartLight EAS is a catheter ablation system that incorporates, for the first time, an endoscope for direct visualization of a beating heart, in real-time and without radiation. It also includes a compliant, dynamically adjustable balloon catheter designed for improved contact with the pulmonary vein (PV) ostium (opening) irrespective of the individual patient anatomy, and utilizes laser energy for more efficient, durable and precise ablation treatment.

"Pulmonary vein isolation is a critical indicator of success in catheter ablation procedures for AF; however, this has traditionally been a very challenging and complex endeavor requiring an experienced operator, multiple ablation devices to account for varied patient anatomy, and even multiple transseptal punctures for access," said Dr. Schmidt. "In this study we set out to examine the feasibility of performing a streamlined, visually-guided ablation procedure and record best practices to achieve endpoints of acute and chronic success.  Our findings demonstrate that this unique approach to ablation may prove highly effective in treating AF patients."

In the study, "Visually Guided Sequential Pulmonary Vein Isolation: Insights into Techniques and Predictors of Acute Success," physicians performed ablation with a single HeartLight EAS and single transseptal puncture on 35 patients with drug-refractory paroxysmal or persistent AF. PV isolation was achieved in 70% (96/137) of veins with an initial ablation. After assessment with a circular mapping catheter, continued ablation with the same HeartLight EAS device resulted in an overall 98% single procedure PV isolation rate. 

Procedures were performed in a mean time of 154+ 38 min, with the ablation stage lasting an average of 89+ 16 min and mean fluoroscopy time of 16 + 6 min. Notably, between the first and last 12 cases a reduction in procedure time was observed (175 + 48 min vs. 138 + 26 min). The primary efficacy endpoint of the study was acute PVI, with a secondary endpoint of freedom from AF between 90 and 365 days post-ablation and off antiarrythmic drugs. During a median follow-up of 266 days, 77% (27/35) of patients remained free of any tachyarrhythmia recurrence and off drugs.

"With the increasing use of catheter ablation as a treatment option for AF patients, the short learning curve and simplified approach enabled by the HeartLight EAS makes this a very promising system, especially as the technique continues to be adopted outside specialized ablation centers," continued  Dr. Schmidt. "In the paper we documented our approach to performing ablation on our center's first series of patients to undergo treatment with the HeartLight EAS, and we believe that as the procedure continues to be standardized, additional centers will experience these impressive, reproducible results."

"In this study, physicians have demonstrated a high rate of clinical success achievable within a reasonably short procedure time, even among operators still in the midst of the learning curve," said Stephen Sagon, President and CEO of CardioFocus. "This reinforces the advantages of HeartLight EAS' novel, adaptable and user-friendly design, and we look forward to continued positive experiences from this and other medical centers as they begin to standardize and master this ablation approach."

For more information on HeartLight EAS, 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. The device is investigational in the U.S., with a pivotal study expected to commence 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.

B Schmidt et al: Visually Guided Sequential Pulmonary Vein Isolation: Insights into Techniques and Predictors of Acute Success. Journal of Cardiovascular Electrophysiology. 2012 Jan 9; DOI: 10.1111/j.1540-8167.2011.02247.x http://onlinelibrary.wiley.com/doi/10.1111/j.1540-8167.2011.02247.x/abstract

 

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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