MARLBOROUGH, Mass., April 10, 2013 /PRNewswire/ -- CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), announced today that cardiologists throughout Germany gathered to discuss clinical experiences with the HeartLight System and its role in the treatment of advanced AF. The featured event was held on April 3, in conjunction with the 79th Annual Meeting of the German Cardiac Society in Mannheim, Germany.
The Symposium, titled “Visually Guided Laser Balloon Ablation: 1,000 Patients Ablated in Germany,” focused on clinical advances with the HeartLight System since its introduction into Germany. It highlighted insights into achieving durable pulmonary vein isolation and optimizing long-term procedure efficacy. The program was chaired by cardiologists Prof. Claus Schmitt, MD of Karlsruhe Hospital, Karlsruhe, Germany and Prof. Andreas Gotte, MD, of St. Vincenz Hospital, Paderborn, Germany.
Prof. Schmitt commented, “The HeartLight System is fast becoming an established AF treatment option at many centers across Germany and throughout Europe, as physicians continue to document positive patient outcomes and impressive long-term success rates. Our broad experiences in learning and adapting the technology over the past several years provided for rigorous discussion at the Symposium. We look forward to continuing to bring forth new insights into the System’s clinical use.”
During the program, researchers from Asklepios Hospital St. Georg in Hamburg, Germany reported chronic follow-up data using the HeartLight System that demonstrated 75% of patients maintained sinus rhythm post procedure. They noted these findings are comparable to, and may offer improvement over, traditional RF and Cryoballoon ablation systems. Other groups presented on topics including the safety profile of the technology, best practices for achieving complete pulmonary vein isolation, and the potential applicability of HeartLight in addressing persistent AF.
Stephen Sagon, President of CardioFocus, said, “The studies highlighted at the Symposium focused on the versatility of the system, with respect to any patient anatomy, and the promise of laser energy in achieving durable pulmonary vein isolation. Cardiologists in Germany are among those at the forefront of AF ablation research. We are excited by their experiences with HeartLight over the previous 1,000 cases and eager to continue to see the impact of improved clinical outcomes.”
This technology was also highlighted in two recent publications in the journals Circulation: Arrhythmia and Electrophysiology and Expert Reviews in Medical Devices. The article in Circulation, authored by Srinivas Dukkipati, MD, of the Mount Sinai School of Medicine in New York, NY, USA featured outcomes from the first 200 patients treated with the HeartLight System across 15 different medical centers.[1] In these initial cases, operators were able to achieve 99% acute isolation; the majority of patients remained free from AF and off anti-arrhythmic drugs at 12 months follow-up. Researchers concluded that their findings point to a short learning curve with HeartLight technology. The article was published online April 4.
The clinical review article published in the March issue of Expert Reviews in Medical Devices was authored by Stefano Bordignon, MD and colleagues from Cardioangiologisches Centrum Bethanien in Frankfurt, Germany. [2] It discussed the unique design of the catheter ablation system, and noted HeartLight is the first cardiac ablation catheter to incorporate an endoscope for direct visualization of the beating heart, a laser energy source and a compliant balloon catheter to conform to virtually any pulmonary vein anatomy. The researchers posited that if larger clinical studies continue to substantiate the outcomes achieved to date, then the system would offer a new paradigm in arrhythmia ablation.
To learn about CardioFocus and the HeartLight System, please visit www.CardioFocus.com.
About CardioFocus, Inc.
CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). Its novel HeartLight® Endoscopic Ablation System for catheter ablation incorporates an endoscope to provide physicians with the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.
The HeartLight Endoscopic Ablation System is commercially available at leading institutions throughout Europe and in Australia. The device is investigational in the U.S., and currently the focus of a pivotal trial initiated in 2012. CardioFocus is headquartered in Marlborough, MA, USA. For more information on the company and its technology, please visit www.CardioFocus.com.
The scientific information discussed in this news release is preliminary and investigative. The CardioFocus HeartLight Endoscopic Ablation System is not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the system. Only FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.
[1] S Dukkipati et al. “Pulmonary Vein Isolation Using a Visually-Guided Laser Balloon Catheter: The First 200-Patient Multicenter Clinical Experience.” Circ Arrhythm Electrophysiol. 2013 online. http://circep.ahajournals.org/content/early/2013/04/04/CIRCEP.113.000431.abstract?sid=905d5db4-754e-4429-bfe1-3c1153bbe827
[2] S Bordignon et al. “Endoscopic ablation systems.” Expert Rev. Med. Devices. 2013;10(2), 177-183. http://www.expert-reviews.com/doi/abs/10.1586/erd.12.86
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