Presentations From Recent Heart Rhythm Society Meeting Validate the Safety and Efficacy of Ablation Frontiers Technology
Published: May 27, 2008
CARLSBAD, Calif., May 23 /PRNewswire/ -- Ablation Frontiers, Inc. today announced that four presentations at the Heart Rhythm Society's 2008 Scientific Sessions reported positive early results using its novel Catheter Ablation System, and that these findings aligned well with each other and supported previous experience from the field.
The company's innovative multi-electrode mapping and ablation catheters used in conjunction with its duty-cycled radiofrequency (RF) generator were the subject of four presentations (AB9-3, AB9-5, PO5-17, and PO6-32). Three of these reports examined early outcomes using the advanced ablation system to treat atrial fibrillation (AF) patients in commercial procedures throughout Europe, while the fourth presentation focused on the feasibility phase for a US-based clinical study.
"In more than 1,000 commercial cases in Europe our technology has been very safe, highly effective and reduced procedures to well under 2 hours. Our commercial experiences are nicely substantiated by the four presentations given at HRS," stated Keegan Harper, CEO of Ablation Frontiers, Inc. "The results presented also align well with each other, with a total of 230 patients showing no adverse events, approximately 80 percent efficacy, and average procedure times ranging from 85 to 129 minutes."
The largest study included 132 patients with paroxysmal AF and was presented by Dr. Lam Dang of the Klinik Im Park in Zurich, Switzerland. He reported a procedure time of 129 +/- 36 minutes with no device-related complications. At the time of presentation, 80 percent of patients with 6 month follow-up were free from AF and had discontinued drug therapy.
Dr. Lucas Boersma of St Antonius Hospital in Nieuwegein, The Netherlands presented two abstracts that studied 85 patients with paroxysmal AF who were treated with the Ablation Frontiers system. These presentations demonstrated a 100 percent acute success rate, no peri/post-procedure complications up to 7 days, and procedure time of 85 +/- 33 minutes. Of those patients monitored at the 6 month follow-up date, 83 percent were free of AF and off anti-arrhythmic drugs.
A smaller study of 20 patients with permanent AF was presented by Dr. Gregory Michaud, Director of the Center for the Advanced Management of Atrial Fibrillation at the Brigham and Women's Hospital in Boston. This data represented procedures performed by 12 first-time operators as part of the feasibility phase of a US clinical trial called TTOP-AF, or the Tailored Treatment of Permanent AF, which is currently enrolling patients. Dr. Michaud reported that 96 percent of patients experienced a procedural success rate with no complications reported. At 6 months follow up, 75 percent of patients were in sinus rhythm, free of AF. After receiving early data from this group of patients, the Food and Drug Administration (FDA) allowed commencement of the pivotal TTOP-AF trial in the US.
"These early reports are extremely promising," noted Dr. Boersma, "and we are hopeful that long-term data will maintain consistency with the results presented. As physicians, we are excited about the remarkably close alignment of these safety and efficacy outcomes, with greatly reduced procedure times, in both the paroxysmal and permanent AF populations."
Atrial Fibrillation is a common and devastating cardiac rhythm disorder in which the heart's upper chambers beat in an extremely fast and chaotic rhythm. Symptoms may include palpitations, dizziness and shortness of breath. AF can present in different forms including paroxysmal, in which the abnormal rhythm starts and stops on its own, or permanent, which does not stop on its own and cannot be stopped with currently available medical treatments (drugs or cardioversion). Left untreated, AF patients are at an increased risk for stroke and may also develop heart failure or other cardiac disorders.
About Ablation Frontiers
Ablation Frontiers is an emerging, venture-backed medical device company based in Carlsbad, California. The company received $21.8 million Series C financing in June 2007, led by the Novartis Venture Fund, to drive clinical development and market expansion for their novel Cardiac Ablation System. Founded in 2004, Ablation Frontiers is dedicated to helping individuals suffering from atrial fibrillation and other cardiac arrhythmias. Working in concert with clinical experts in the field of ablation, the company is focused on developing and commercializing innovative products designed to make ablation procedures safer and less time consuming thereby making it possible for more individuals to benefit from this life-bettering therapy. In late 2006, Ablation Frontiers received the CE Mark to begin marketing in the European Union with its portfolio of anatomical-based catheters and a multi-channel RF generator. To learn more about the company, visit http://www.ablationfrontiers.com.
CONTACT: Jay Kelley, Global Marketing Manager of Ablation Frontiers, Inc.,
Web site: http://www.ablationfrontiers.com/