CardioFocus Gains European CE Mark for HeartLight Excalibur Laser Ablation Balloon

October 10, 2017 — CardioFocus Inc. recently announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF).

The Excalibur Balloon leverages the universal balloon design of the company's U.S. Food and Drug Administration (FDA)-approved HeartLightEndoscopic Ablation System and introduces an advanced feature set that optimizes the speed and magnitude of target tissue contact during pulmonary vein isolation (PVI) procedures.

More than 33 million patients worldwide suffer from AF.¹ In Europe alone, it is estimated that the number of patients will rise to 14-17 million by 2030².

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 designed to maximize the engagement of the balloon with the pulmonary veins, while decreasing the time required to complete ablation procedures.

"We are delighted by the results we experienced during our clinical evaluation of the HeartLight Excalibur Balloon," said Prof. Petr Neužil from Na Homolce Hospital, in Prague, Czech Republic. "We consistently noted that the Excalibur Balloon is easier and faster to use, establishes significantly more contact with the vein and can consistently obtain an impressive antral position. I believe that this next-generation balloon will receive an enthusiastic reception by my physician colleagues."

The company plans to initiate a controlled launch of the Excalibur Balloon in Europe beginning in the fourth quarter of this year.

The Excalibur generation of the CardioFocus HeartLight System is not approved by the FDA and is investigational in nature outside of the EU.

Watch the VIDEO "Current State of Atrial Fibrillation Ablation Technologies," an interview with Hugh Calkins, M.D., at the Heart Rhythm Society (HRS) 2017 Annual Meeting.

Watch the VIDEO "Editor's Choice of Most Innovative New Technology at HRS 2017."

For more information: www.cardiofocus.com

References

1. Chugh SS, Havmoeller R, Narayanan K, et al.; Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47.

2. Zoni-Berisso, Massimo et al. "Epidemiology of Atrial Fibrillation: European Perspective." Clinical Epidemiology 6 (2014): 213–220. PMC. Web. 25 July 2017.