FDA Grants Approval to Extend U.S. Enrollment and Clin...( Ablation Frontiers Uses Novel Techn...),Health

Ablation Frontiers Uses Novel Technology in Treatment of Chronic Atrial

Fibrillation Patients

CARLSBAD, Calif., Jan. 16 /PRNewswire/ -- Ablation Frontiers, Inc. today announced the expansion of enrollment in the first ever U.S. Investigational Device Exemption (IDE) clinical trial for interventional treatment of chronic atrial fibrillation (AF). Approval from the US Food and Drug Administration (FDA) to proceed with the pivotal phase of the study is based on the review of an initial feasibility segment completed in August 2007. Completion of the clinical trial, which will compare the safety and efficacy of tailored ablation therapy against traditional pharmaceutical regimens, will support a pre-market approval (PMA) application to the FDA.

Having received FDA approval to enter the pivotal phase of the trial in the fourth quarter of 2007, several patients have already been randomized into the study. Initial US treatment sites included The Lahey Clinic and Medical Center in Burlington, Massachusetts. Their first patient, with a three year history of continuous AF, was successfully treated and returned home the next day with a normal heart rhythm. After the two-hour and ten-minute procedure, Dr. Gregory Michaud had the following enthusiastic comment, "I am really excited about this new technology. It has two advantages that are immediately apparent. One, the catheters are simpler to use than the traditional 'point-by-point' catheters, thus reducing the time it takes to complete complex left atrial procedures. Second, the depth of the radiofrequency energy lesions is controllable, which makes damage to collateral structures, such as the esophagus, less likely."

The Ablation Frontiers Cardiac Ablation System, being evaluated in this clinical study, was developed under the guidance of Drs. Fred Morady and Hakan Oral, at the University of Michigan. Designed to be a versatile tool kit for mapping and ablating areas of t
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