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Presentations From Recent Heart Rhythm Society Meeting Validate the Safety and Efficacy of Ablation Frontiers Technology in 230 Patients
Date:5/23/2008

lation 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 s
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SOURCE Ablation Frontiers, Inc.
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