MARLBOROUGH, Mass., Jan. 5, 2015 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), today announced that it has executed an exclusive, multi-year distribution agreement with Japan Lifeline Co., Ltd.
Atrial fibrillation (AF) is the most common sustained arrhythmia and presents elevated risk factors for both stroke and death. It is estimated that more than 1 million people in Japan currently suffer from this debilitating disease. Individuals affected by AF have been increasing worldwide due to an aging population and continued increases in the prevalence and incidence of AF are expected.
Hiroshi Nakagawa, MD, Ph.D., Professor of Medicine at the University of Oklahoma Health Sciences Center, Director, Clinical Catheter Ablation Program, and Director, Translational Electrophysiology commented: "While conventional RF ablation technology to treat AF is widely used, it is typical for patients treated with conventional technology to have their arrhythmia recur after one and even after several ablations. The CardioFocus HeartLight is a unique ablation technology that promises to reduce the need for multiple procedures. Its direct endoscopic visualization enables precise placement of ablation energy. This results in the creation of continuous lesions around the pulmonary veins which are essential for long lasting elimination of AF. The compliant balloon guarantees an anatomical fit to all types of patient anatomies so the risk of delivering energy too far into the vein and causing complications is minimized. Laser energy creates lesions deep enough to treat the arrhythmia without excess damage to either the endocardial surface or structures surrounding the left atrium. Laser power may also be adjusted to match the differing requirements of various parts of the atrium. This capability increases the efficacy, (durable pulmonary vein isolation), and safety, (reduction of collateral damage), for AF ablation procedures."
"Now that more than 2,500 patients have been treated using the HeartLight system and our US Pivotal Trial has entered the analysis phase, we're confident about our clinical utility and eager to extend the availability of our products to Japan, one of the largest medical markets in the world. Our company has been pleased to find such a talented and capable team as the JLL group with whom to entrust our products and pursue this substantial opportunity," said Stephen Sagon, President of CardioFocus.
"The CardioFocus HeartLight System has been clinically validated and provides an important advance to our product offering for the treatment of arrhythmias in Japan," said Keisuke Suzuki, President and CEO of Japan Lifeline. "Our company has a long tradition of both manufacturing and distributing innovative products for the diagnosis and treatment of arrhythmias. It is now our goal to help the HeartLight platform become widely used in atrial fibrillation ablation."
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 incorporates a compliant balloon and 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 is currently the focus of a recently concluded pivotal trial with results pending. CardioFocus is headquartered in Marlborough, MA, USA. For more information on the company and its technology, please visit www.CardioFocus.com.
About Japan Lifeline Co., Ltd.
Japan Lifeline (JLL) has a 33-year history as a manufacturer, importer and distributor of quality medical products. Japan Lifeline will sell the HeartLight products through its electrophysiology division, which includes more than 200 field personnel across thirty three offices. JLL has a strong track record of success in building and expanding markets with unique products from some of the world's leading medical technology companies. Japan Lifeline is a publicly traded company, ticker symbol 7575 (JASDAQ). Visit the JLL website at: http://www.japanlifeline.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.
Warren (Renny) Clark III
Chief Financial Officer
SOURCE CardioFocus, Inc.