Advertisement
The company's innovative multi-electrode mapping and ablation cathetersused in conjunction with its duty-cycled radiofrequency (RF) generator werethe subject of four presentations (AB9-3, AB9-5, PO5-17, and PO6-32). Three ofthese reports examined early outcomes using the advanced ablation system totreat atrial fibrillation (AF) patients in commercial procedures throughoutEurope, while the fourth presentation focused on the feasibility phase for aUS-based clinical study.
Advertisement
"In more than 1,000 commercial cases in Europe our technology has beenvery safe, highly effective and reduced procedures to well under 2 hours. Ourcommercial experiences are nicely substantiated by the four presentationsgiven at HRS," stated Keegan Harper, CEO of Ablation Frontiers, Inc. "Theresults presented also align well with each other, with a total of 230patients showing no adverse events, approximately 80 percent efficacy, andaverage procedure times ranging from 85 to 129 minutes."
The largest study included 132 patients with paroxysmal AF and waspresented by Dr. Lam Dang of the Klinik Im Park in Zurich, Switzerland. Hereported a procedure time of 129 +/- 36 minutes with no device-relatedcomplications. At the time of presentation, 80 percent of patients with 6month follow-up were free from AF and had discontinued drug therapy.
Dr. Lucas Boersma of St Antonius Hospital in Nieuwegein, The Netherlandspresented two abstracts that studied 85 patients with paroxysmal AF who weretreated with the Ablation Frontiers system. These presentations demonstrateda 100 percent acute success rate, no peri/post-procedure complications up to 7days, and procedure time of 85 +/- 33 minutes. Of those patients monitored atthe 6 month follow-up date, 83 percent were free of AF and off anti-arrhythmicdrugs.
A smaller study of 20 patients with permanent AF was presented by Dr.Gregory Michaud, Director of the Center for the Advanced Management of AtrialFibrillation at the Brigham and Women's Hospital in Boston. This datarepresented procedures performed by 12 first-time operators as part of thefeasibility phase of a US clinical trial called TTOP-AF, or the TailoredTreatment of Permanent AF, which is currently enrolling patients. Dr. Michaudreported that 96 percent of patients experienced a procedural success ratewith no complications reported. At 6 months follow up, 75 percent of patientswere in sinus rhythm, free of AF. After receiving early data from this groupof patients, the Food and Drug Administration (FDA) allowed commencement ofthe pivotal TTOP-AF trial in the US.
"These early reports are extremely promising," noted Dr. Boersma, "and weare hopeful that long-term data will maintain consistency with the resultspresented. As physicians, we are excited about the remarkably close alignmentof 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 inwhich the heart's upper chambers beat in an extremely fast and chaotic rhythm.Symptoms may include palpitations, dizziness and shortness of breath. AF canpresent in different forms including paroxysmal, in which the abnormal rhythmstarts and stops on its own, or permanent, which does not stop on its own andcannot be stopped with currently available medical treatments (drugs orcardioversion). Left untreated, AF patients are at an increased risk forstroke and may also develop heart failure or other cardiac disorders.
About Ablation Frontiers
