Technology | Ablation Systems | October 10, 2017

CardioFocus Gains European CE Mark for HeartLight Excalibur Laser Ablation Balloon

Next-generation technology optimizes speed and magnitude of target tissue contact during pulmonary vein isolation procedures

CardioFocus Announces European CE Mark Approval of HeartLight Excalibur 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.

Related Content

FDA Approves Biosense Webster's Tag-Index Guided Ablation Software
Technology | Ablation Systems | October 09, 2018
Biosense Webster Inc. recently received approval from the U.S. Food and Drug Administration (FDA) for its Visitag...
Medtronic Cryoballoon Improves Quality of Life, Reduces Systems of Persistent Atrial Fibrillation
News | Ablation Systems | August 28, 2018
Medtronic plc announced new findings from the CRYO4PERSISTENT AF clinical trial demonstrating improved quality of life...
Thermedical Announces FDA IDE Approval for Clinical Study of Durablate Catheter
News | Ablation Systems | August 02, 2018
Thermedical announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device...
Boston Scientific to Acquire Cryterion Medical Inc.
News | Ablation Systems | July 13, 2018
Boston Scientific Corp. recently announced a definitive agreement to acquire Cryterion Medical Inc., a privately-held...
Treating AFib With Ablation Reduces Mortality and Stroke
News | Ablation Systems | July 05, 2018
Using catheter-based ablation instead of medications alone reduces the risks of death and stroke in patients with the...
LuxCath Showcases OmniView Light-Guided Ablation Catheter at HRS 2018
News | Ablation Systems | May 22, 2018
LuxCath LLC showcased the next generation of its proprietary OmniView light-guided catheter ablation system at the 2018...
The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously.  #HRS2018

The Kardium Globe combined mapping and ablation catheter. The device has a distal multi-electrode array consisting of 16 ribs with 122 gold-plated electrodes. Ablation can be done with up to 24 electrodes simultaneously. 

News | Ablation Systems | May 21, 2018
May 21, 2018 — Complete pulmonary vein isolation (PVI) was achieved in more than 99 percent of patients in a first-in
CardioFocus Announces Successful Live Case Featuring HeartLight X3 System
News | Ablation Systems | May 17, 2018
Medical device manufacturer CardioFocus Inc. announced a successful live case featuring its HeartLight X3 System during...
Imricor MRI-Guided Cardiac Ablation Study Results to Be Presented at HRS 2018
News | Ablation Systems | May 10, 2018
Results from the clinical study to evaluate Imricor’s Vision-MR Ablation Catheter for the treatment of atrial flutter...
Biosense Webster Launches Carto Vizigo Bi-Directional Guidance Sheath
Technology | Ablation Systems | May 08, 2018
Biosense Webster Inc. announced its Carto Vizigo Bi-directional Guiding Sheath is now available in the United States....
Overlay Init