CardioFocus® Announces Initial Clinical Evaluation of Next-Generation HeartLight® Excalibur Balloon™ Designed For the Treatment of Atrial Fibrillation

MARLBOROUGH, Mass., Jan. 19, 2017 /PRNewswire/ -- CardioFocus, Inc. today announced the initial clinical evaluation of the HeartLight® Excalibur Balloon™, a next-generation technology designed for the treatment of atrial fibrillation (AF). The Excalibur Balloon leverages the proven universal balloon design of the HeartLight Endoscopic Ablation System and introduces an advanced feature set that optimizes the speed and magnitude of target tissue contact during pulmonary vein isolation (PVI) procedures.

A live patient case featuring the HeartLight Excalibur Balloon was included in the session, "Advances in Catheter Ablation for AF and Left Atrial Appendage Closure," at the 22^nd Annual AF Symposium on Friday, Jan. 13. The live case was performed by Prof. Petr Neužil, Dr. Lucie Šedivá, Dr. Jan Petrů and Dr. Jan Skoda from Na Homolce Hospital, in Prague, Czech Republic.

"The HeartLight Excalibur Balloon conforms effectively to the range of anatomies that we encounter during PVI procedures," said Dr. Jan Petrů, Head of the Electrophysiology Laboratory. "It is also very responsive, which may result in both better procedural efficiencies and potentially better patient outcomes. We are very pleased with the experience thus far."

In addition to a more compliant construction that enables adaptive vein conformance, the Excalibur Balloon also incorporates proprietary Dynamic Response™ technology. This feature makes the balloon highly responsive to a range of user techniques and amounts of pressure applied, while optimizing vein contact. The result is a design meant to maximize the engagement of the balloon with the pulmonary veins, while decreasing the time required to complete ablation procedures.

"The new HeartLight Excalibur Balloon is designed to capitalize on the existing features of our HeartLight System, which offers an accurate, consistent and controlled treatment option for AF patients whose heart arrhythmias are insufficiently controlled with medication," said Paul A. LaViolette, Executive Chairman of CardioFocus. "We are encouraged by the positive feedback we have received and the early clinical outcomes," LaViolette added.

The HeartLight Excalibur Balloon is undergoing an initial clinical evaluation in Europe as part of a broader development program that seeks to confirm its design objectives.

About the HeartLight Endoscopic Ablation System

The HeartLight Endoscopic Ablation System is a revolutionary catheter ablation technology designed for the treatment of atrial fibrillation (AF), the most common heart arrhythmia. The HeartLight System's direct visualization, titratable laser energy, and universal balloon design make it a new standard for pulmonary vein isolation (PVI) procedures. The HeartLight System is approved for use and commercially available in the United States and Europe. More than 3,800 patients with AF have been successfully treated with the system.

The HeartLight Excalibur Balloon information discussed in this release is preliminary and investigative. The Excalibur Generation of the CardioFocus HeartLight System is not approved by the U.S. Food and Drug Administration (FDA) and is investigational in nature. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.

About CardioFocus, Inc.

CardioFocus is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). The company's HeartLight Endoscopic Ablation System is commercially available at leading institutions throughout the United States and Europe. CardioFocus is headquartered in Marlborough, Mass. For more information on the company and its technology, please visit www.cardiofocus.com.

Media Contact:                                                     
Susan Benton Russell
Phone: 310.699.1132
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SOURCE CardioFocus, Inc.

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