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

Stereotaxis Receives Regulatory Approval of e-Contact Module in Canada
Technology | Ablation Systems | December 08, 2017
December 7, 2017 — Stereotaxis Inc.
The Apama Radiofrequency (RF) Balloon Catheter System.
News | Ablation Systems | October 02, 2017
October 2, 2017 — Boston Scientific announced a definitive agreement to acquire Apama Medical Inc., a privately-held
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems | August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Medtronic Announces First Enrollments in STOP AF First Clinical Trial
News | Ablation Systems | July 24, 2017
Medtronic plc recently announced first enrollments in the STOP AF First clinical trial. The trial will evaluate the...
Biosense Webster multi-electrode RF ablation balloon

Biosense Webster's multi-electrode RF ablation balloon with irrigation. The system allows operators to change the energy levels of each electrode to avoid damaging sensitive underlying critical structures like the esophagus or phrenic nerve.

Feature | Ablation Systems | May 17, 2017 | Dave Fornell
May 17, 2017 – Clinical trial results from a first-in-human study evaluating the acute feasibility of an investigatio
Abbott Announces CE Mark for New Cardiac Ablation Catheter
News | Ablation Systems | May 10, 2017
Abbott announced CE Mark of the TactiCath Contact Force Ablation Catheter, Sensor Enabled, developed to make it easier...
Medtronic, expanded indication, Freezor Xtra Cryoablation Catheter, AVNRT, atrioventricular nodal re-entrant tachycardia
Technology | Ablation Systems | February 16, 2017
Medtronic plc announced the U.S. Food and Drug Administration (FDA) has approved its Freezor Xtra Cryoablation Catheter...
CardioFocus, HeartLight Excalibur Balloon, 22nd Annual AF Symposium, atrial fibrillation, initial clinical evaluation
News | Ablation Systems | January 25, 2017
CardioFocus Inc. recently announced the initial clinical evaluation of the HeartLight Excalibur Balloon, a next-...
catheter ablations, atrial fibrillation, stroke risk, Intermountain Medical Center Heart Institute study, AHA Scientific Sessions, American Heart Association
News | Ablation Systems | November 14, 2016
Atrial fibrillation patients with a prior history of stroke who undergo catheter ablation lower their long-term risk of...
Medtronic, FIRE AND ICE trial, Arctic Front, cryoballoon catheter ablation, radiofrequency RF ablation, study results, Asia Pacific Heart Rhythm Society Scientific Sessions
News | Ablation Systems | October 17, 2016
Medtronic plc last week unveiled new health economic analysis data from the FIRE AND ICE trial that favor cryoballoon...
Overlay Init