MARLBOROUGH, Mass., Aug. 1 /PRNewswire/ -- CardioFocus, Inc. announced today that it has been awarded CE Mark approval for its proprietary Endoscopic Ablation System. This novel transvenous device combines real-time, full color, endoscopic visualization and guidance with the delivery of therapeutic light energy to perform pulmonary vein isolation for the treatment of atrial fibrillation.
The Endoscopic Ablation System has been designed to treat the most common heart rhythm disturbance called atrial fibrillation, a disease affecting more than 5 million people in Europe and in the United States in addition to millions more worldwide. "We're very gratified to have achieved this level of confirmation for the work we have accomplished and the potential for aiding patients afflicted with atrial fibrillation worldwide," said Stephen Sagon the Company's President and CEO. "The CE Mark confirms our satisfaction of the EU medical device directives and assures patients and clinicians that our European clinical results and our manufacturing quality systems are of high caliber."
The CardioFocus Endoscopic Ablation System has also received US IDE approval for clinical investigation in a randomized, multi-center study, currently underway and enrolling patients at over a dozen leading medical centers across the country. Patients with symptomatic paroxysmal atrial fibrillation may learn about inclusion and exclusion criteria for the ENABLE trial, including information about participating centers at: http://www.clinicaltrials.gov/ct/show/NCT00477230?order=1
Study co-principal investigator Andrea Natale, MD of the Cleveland Clinic Foundation commented, "I am very satisfied with our ability to access anatomical targets and to achieve electrical isolation. The real-time view using the Endoscopic Ablation System provides a truly unique opportunity to tailor ablation therapy in a highly variable clinical setting." His colleague and study co-principal investigator Vivek Reddy of the Massachusetts General Hospital said, "Today, there are no devices specifically approved in the U.S. to treat this challenging arrhythmia. Multiple products are being used to pursue a variety of different strategies, but these are limited by the inability to directly visualize the tissue being ablated. The CardioFocus technique provides a new capability to directly address the difficult navigational challenges clinicians face in treating patients with symptomatic paroxysmal atrial fibrillation".
About Atrial Fibrillation
AF is a potentially serious cardiac arrhythmia typically requiring treatment for, rate and / or rhythm control as well as anticoagulation therapy to help contend with the elevated risk of stroke. In a recent statement issued by the Heart Rhythm Society, the European Heart Rhythm Association and the European Cardiac Arrhythmia Society, The Task Force on Catheter and Surgical Ablation of Atrial Fibrillation wrote: "There is a consensus among the Task Force that the primary indication for catheter AF ablation is the presence of symptomatic AF, refractory or intolerant to, at least one Class 1 or Class 3 antiarrhythmic medication". They further indicated that: a) ablation strategies that target the pulmonary veins (PV) and / or PV antrum are the cornerstone for most AF ablation procedures; b) if the PVs are targeted, complete electrical isolation should be the goal; and, c) careful identification of the PV ostia is mandatory to avoid ablation within the PVs.
About CardioFocus, Inc.
CardioFocus, Inc. is a venture-backed medical device company based in Marlborough, Massachusetts. The company is developing, manufacturing and investigating proprietary, disposable fiber optic catheters for the visualization of the cardiac anatomy and the treatment of cardiac arrhythmias such as atrial fibrillation. For more information, visit http://www.cardiofocus.com.
|SOURCE CardioFocus, Inc.|
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