Healthcare Industry News: U.S. Food and Drug Administration
News Release - September 27, 2017
CardioFocus(R) Announces European CE Mark Approval Of The Next-Generation HeartLight(R) Excalibur Balloon(TM) Designed For The Treatment Of Atrial FibrillationMARLBOROUGH, Mass., Sept. 27, 2017 -- (Healthcare Sales & Marketing Network) -- CardioFocus, Inc. today 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 proven universal balloon design of the company's FDA-approved 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.
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.
"The new HeartLight Excalibur Balloon is designed to capitalize on the existing features of our HeartLight System, which offer an accurate, consistent and controlled treatment option for AF patients whose heart arrhythmias are insufficiently controlled with medication. Excalibur will make the procedure even easier to perform," said Burke T. Barrett, Chief Operating Officer of CardioFocus. "The timely clinical evaluation and subsequent approval of Excalibur in Europe reflects the strong performance of the technology and highlights the significant advances made with the Excalibur Balloon."
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.
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 approved for use in the United States, Europe and Japan. The HeartLight 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. More than 4,500 patients with AF have been successfully treated with the system. CardioFocus is headquartered in Marlborough, Mass. For more information visit www.cardiofocus.com.
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 outside of the EU. Healthcare professionals in the U.S. should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.
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.
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