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Studies of an Innovative Catheter Ablation System for Atrial Fibrillation Reveal Excellent Outcomes, Safety Profile and Fast Procedure Times
Date:6/24/2008

Presentations at Cardiostim World Congress Focus Attention on a New

Ablation Technology

CARLSBAD, Calif., June 24 /PRNewswire/ -- Ablation Frontiers, Inc. today announced that two studies reporting positive findings about its novel atrial fibrillation catheter ablation system were presented at this year's Cardiostim World Congress, a premier meeting for physicians that treat cardiac rhythm disorders.

Dr. Stefan Weber of the University Clinic at Regensburg, Germany, presented results of a study of 12 patients with paroxysmal atrial fibrillation (PAF). Using the company's PVAC(TM) (Pulmonary Vein Ablation Catheter) and GENius(TM) RF generator, Dr. Weber reported success in isolating 98 percent of pulmonary veins with a remarkably short average ablation time of 84 +/- 9 minutes. The total time of radiofrequency (RF) energy needed to successfully isolate the pulmonary veins was 22.4 +/- 2.9 minutes.

"We found that mapping and ablation of the pulmonary veins using a single catheter, without 3D navigation or robotic steering, could be performed safely and effectively with short procedure times," stated Dr. Weber. "Thus, this system may be of high interest for all centers who would like to increase throughput for AF ablation."

The second study, led by Dr. Christoph Scharf and presented by Dr. Lam Dang of Klinik Im Park Hospital in Zurich, Switzerland, utilized the same novel catheter ablation technology in a total of 45 patients with long standing persistent AF. This study utilized two additional catheters from Ablation Frontiers, MASC(TM) (Multi-Array Septal Catheter) and MAAC(TM) (Multi-Array Ablation Catheter) designed to find and ablate specific ablation targets called CFAEs (Complex Fractionated Atrial Electrograms). Six month follow up data was presented for 37 patients, with 78 percent free of AF after an average procedure time of 162 +/- 36 minutes. Dr Scharf noted the particularly low re-do procedure rate of 13.5% and the absence of left atrial flutters after the procedure.

"These early results are very promising and procedure times have been significantly reduced," stated Dr. Scharf. "Using unipolar:bipolar RF energy for the ablation is safer and more effective in our experience. This is an important aspect to this system, as tipped-catheters and conventional higher power RF generators have been associated with significant complications."

The company's innovative multi-electrode mapping and ablation catheters are used in conjunction with its duty-cycled radiofrequency (RF) generator. Each catheter's adaptable shape facilitates access to and good tissue contact with the left atrial regions that require ablation to terminate atrial fibrillation. The temperature controlled, power limited energy source was specifically designed to reduce the risk of complications seen with conventional higher-energy power sources.

"While isolation of the pulmonary veins can be effective in treating paroxysmal AF, long-standing persistent AF requires that other areas of the left atrium be specifically targeted. Conventional ablation technology offers only one therapeutic option for both disease states, which has produced moderate success, relatively high rates of complications, and long procedure times. Ablation Frontiers' family of catheters delivers innovative solutions for treating both paroxysmal and long standing persistent AF patients," stated Keegan Harper, Chief Executive Officer of Ablation Frontiers. "We are very gratified to see our products working in both AF patient populations with high success rates, very low complication rates, and considerably shortened procedure times."

Atrial fibrillation (AF) 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 long-standing persistent, 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. 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-enhancing 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.


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SOURCE Ablation Frontiers, Inc.
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