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FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial
Date:1/16/2008

he heart where AF is most prevalent, the Cardiac Ablation System combines a novel radiofrequency (RF) energy source with a series of anatomically-designed catheters. The Ablation Frontiers system is also unique because it does not require expensive 3D navigation or robotic steering equipment that can make these types of procedures longer and more complicated.

About the TTOP AF Trial

The study, known as the Tailored Treatment of Permanent Atrial Fibrillation (TTOP AF), uses an approach that allows cardiologists to customize their treatment strategy and potentially shorten procedure times, improve patient outcomes, and reduce recurrence of the disease. "The pivotal phase of the TTOP AF trial is designed to demonstrate the clinical safety and efficacy of our Catheter Ablation System as compared to current drug options," said Ablation Frontiers' Chief Executive Officer, Keegan Harper. "Based on positive clinical outcomes of our multi-center European study, as well as our ongoing commercial experience in Europe, we believe that the TTOP AF trial will show striking clinical benefits made possible by our technology. We have already demonstrated in numerous procedures in Europe that we can greatly reduce procedure times with our technology."

Patients will initially be randomized into two treatment groups; one group receiving ablation therapy, and the other group -- called the control arm -- receiving commonly used drug treatments. For every two patients initially receiving an ablation, one will be randomly assigned to the control arm. The trial allows patients in the control arm to receive an ablation if they do not respond to drug therapy. At the conclusion of the study, Ablation Frontiers will submit a Pre-Market Approval (PMA) application to the FDA for marketing the Catheter Ablation System in the US.

About Atrial Fibrillation

Atrial fibrillation remains the most commonly diagnosed cardiac arrhythmia, or irregular heart rhythm, affecti
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SOURCE Ablation Frontiers, Inc.
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