Regulatory Approval Clears Path Towards European Commercialization
CARLSBAD, Calif., June 7 -- Ablation Frontiers, Inc., developer and manufacturer of three-dimensional catheters for the treatment of atrial fibrillation (AF) announced today that in December 2006, it received the CE Mark for its Cardiac Ablation System consisting of a portfolio of anatomical based catheters and a uniquely designed radiofrequency (RF) energy delivery system. Receipt of the CE Mark certification allowed the company to initiate the first commercial use of its Ablation System on January 18, 2007. The company has initiated a commercial launch of its products with key international cardiac centers throughout the European Union and other International markets that recognize the CE Mark.
Ablation Frontiers proprietary products are designed to treat all types of atrial fibrillation, including patients with paroxysmal, persistent and the more difficult to treat, permanent AF. The novel catheters effectively treat tissue in the right and/or left atrium through percutaneous access to the heart. Ablation Frontiers, Inc. has developed a tool kit of catheters specifically designed for the atrial anatomy and AF ablation. The catheters are powered by a cleverly designed RF energy source that allows a physician to precisely control the energy and tailor treatment for the individual needs of the patient. Design goals centered on the need to develop a very simple but elegant therapy solution that could greatly reduce procedure times, improve safety and be easily learned by most electrophysiologists. Unlike all other treatment approaches, this technology does not rely on expensive three-dimensional mapping or complex catheter steering robotics. The Company's percutaneous cardiac catheters are inserted through a patient's leg vein and advanced into the right and/or left atrium. Each catheter is designed to map, and using radiofrequency energy, ablate specific target sites through simultaneous selective combinations of multiple electrode channels.
The unique catheter designs result in increased accuracy for the physician due to the stabilizing nature of the three-dimensional catheters and the multi-array of electrodes on each catheter. The Ablation Frontiers Cardiac Ablation System allows physicians to tailor the ablation therapy to suit the needs of each patient in as much as half the time as a conventional point to point catheter ablation procedure. Traditional AF ablation procedures currently take up to 4 hours or longer to perform.
"It is truly exciting to be at the forefront of a new technology that can greatly simplify the treatment of atrial fibrillation and result in more patients receiving advanced treatment," stated Keegan Harper, CEO, for Ablation Frontiers.
"This is clearly a therapy designed by electrophysiologists for electrophysiologists. I have been using these catheters on patients with all types of atrial fibrillation, from paroxysmal to the most challenging of longstanding persistent AF. I have achieved excellent early results and outcomes as well as substantially reduced my procedure times", stated Dr Stephen Furniss, Consultant Cardiologist & Hon Senior Lecturer, Freeman Hospital, Newcastle upon Tyne, UK.
"We are very pleased with the results of our European clinical trials, and given the significant customer interest and high level of early adoption, we are looking forward to a more comprehensive launch of our technology into the European and key international markets" stated Martin Chambers, Vice President, Global Sales & Marketing, for Ablation Frontiers.
Ablation procedures are used to treat cardiac arrhythmias, such as atrial fibrillation. AF is an uncontrollable, rapid heartbeat that can lead to serious complications such as strokes or heart failure. Globally, in excess of 10 million people are afflicted with AF. During the ablation procedure, a catheter is inserted into a specific area of the heart. Energy is directed through the catheter to small areas of the heart muscle that permit the abnormal heart rhythm. This energy "disconnects" the pathway of the abnormal rhythm.
The Cardiac Ablation Technology System provides a catheter-based solution to AF that is appropriate for most hospital facilities when performed by a cardiac electrophysiologist.
Ablation Frontiers is a privately held company that was founded in 2004. You can learn more about the company at http://www.ablationfrontiers.com/
Source: Ablation Frontiers, Inc.
CONTACT: Keegan Harper, President and CEO of Ablation Frontiers, Inc.,
+1-760-438-4868, ext. 117
Web site: http://www.ablationfrontiers.com/