EP Lab Digest - March 2008 - (Page 56)

56 NEWS MARCH 2008 FDA Grants Approval to Extend U.S. Enrollment and Clinical Trial Ablation Frontiers Uses Novel Technology in Treatment of Chronic Atrial Fibrillation Patients blation Frontiers, Inc. announced the expansion of enrollment in the U.S. Investigational Device Exemption (IDE) clinical trial for interventional treatment of chronic atrial fibrillation (AF). Approval from the U.S. 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 U.S. 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 tenminute procedure, Dr. Gregory Michaud said, “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 (RF) 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 the heart where AF is most prevalent, the Cardiac Ablation System combines a novel 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. 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 A 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 (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 U.S. Atrial fibrillation remains the most commonly diagnosed cardiac arrhythmia, affecting approximately ten million people worldwide. As the U.S. population ages, it is likely that the incidence of AF will dramatically increase over the next several decades, with an estimated six percent of the current U.S. population over age 60, and ten percent of the population over age 80, affected by the condition.AF is a leading cause of stroke and when left untreated can significantly reduce quality of life and lead to stroke, heart failure and death. Patients with AF today are generally treated with pharmaceutical drug regimens or surgery in more severe cases. Currently, no minimally invasive, catheter-based procedures have been approved by the FDA to treat AF, although an estimated 50,000 procedures will be performed this year. The currently available “tip catheter” approaches are based on a decade-old technology originally designed to treat irregular heart rhythms other than AF. Ablation Frontiers is a medical device company based in Carlsbad, California. Founded in 2004, the company is focused on developing and commercializing innovative products for the treatment of cardiac arrhythmias. 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. extronics, Inc. has received U.S. Food and Drug Administration (FDA) clearance to market its textile-based ECG Electrode for use in general electrocardiograph monitoring and recording procedures.The company’s heart-sensing fabric offers a comfortable alternative to adhesive electrodes and metal wristbands that are commonly used with most ECG instruments on the market. “Our textile electrodes can be worn comfortably against the skin, as part of a seamless garment, fabric chest strap or elastic wrist band,” explains Textronics CEO Textronics, Inc. Receives FDA Clearance on Textile Electrode T Stacey Burr. “We’re offering the medical community a more comfortable and less cumbersome solution that can improve patient compliance by eliminating skin irritation and other discomforts that are commonly experienced during ECG monitoring, especially in extended wear applications.” Textronics uses its patented technology to knit conductive sensing fibers directly into stretchy fabrics that can monitor physiological conditions comfortably and accurately.The company’s textile electrode garments, straps and wristbands are also machine washable and reusable. They can be used for a wide range of ECG monitoring and recording applications, including cardiac event recorders, stress testing, Holter monitoring, trans-telephonic pacemaker monitors, and respiration sensing devices. “We have already reached into fitness and sports markets, where heart rate monitoring is widely used to enhance performance and to ensure safety,” says Burr. “We can now bring our ECG electrode technology to the health care market, where advances in technology are enabling people to monitor their biofeedback from the comfort of their own homes.” http://www.ablationfrontiers.com

Table of Contents Feed for the Digital Edition of EP Lab Digest - March 2008

EP Lab Digest - March 2008 ECG 101: The Case of a Dizzy Patient with a Left Bundle Branch Block Delayed Defibrillation: Research and Results Interview with Paul S. Chan, MD Contents Letter from the Editor Spotlight Interview: St. Joseph’s Hospital Health Center Parent Heart Watch from 36,000 Feet… Perspectives from the Annual Leadership Conference Clinical Trial Overview: 2008 Are MRI-Safe Pacemakers and Leads on the Horizon? Q & A with J. Rod Gimbel, MD Navigating Tortuous Coronary Sinus Anatomy Using a Bipolar Lead Email Discussion Group: March 2008 Guidelines on ECG Interpretation Spotlight Interview Update: What Have We Learned? The Value of Educating Staff Events Calendar Industry News and Products Classifieds Advertisers Index In Memoriam

EP Lab Digest - March 2008

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