AtriCure Announces Initiation Of The ABLATE Pivotal Trial To Evaluate The Isolator Synergy(TM) Bipolar Ablation System To Treat Atrial Fibrillation
The purpose of the ABLATE clinical trial is to evaluate the safety and effectiveness of AtriCure's Isolator Synergy(TM) bipolar ablation system for reestablishing normal heart rhythm in patients with permanent atrial fibrillation, or AF, requiring concomitant open-heart surgery utilizing the Cox Maze IV procedure. The Isolator Synergy(TM) bipolar ablation system is designed to create precise lesions, or scars, on heart muscle, which block irregular electrical signals and restore normal sinus rhythm.
This prospective, non-randomized clinical trial is expected to enroll approximately 70 patients at 10 medical centers in the United States. The primary efficacy endpoints for the trial are patients being free from AF and off anti-arrhythmic drugs at six months. Upon the completion of a successful trial, the results will be submitted to the FDA as part of a Pre-Market Approval, or PMA, in support of an AF indication for our Isolator Synergy(TM) bipolar ablation system when used to treat patients undergoing concomitant open-heart surgery.
Dr. Richard Kaplon commented, "Patients who have AF are at significant risk for stroke and death when compared to patients in normal sinus rhythm. We believe that this is an important treatment for our patients. Based on our group's experience using the Isolator Synergy(TM) bipolar ablation system, we believe that the study endpoints are well designed and that the trial plan will facilitate enrollment."
"According to the American Heart Association, AF is estimated to affect more than 5.5 million people worldwide and is the leading cause of stroke. Due to the lack of AF treatment alternatives, it is important for AtriCure to work closely with the FDA to investigate potentially safer and more effective treatment alternatives for the millions of patients who suffer the debilitating effects of AF," said David J. Drachman, AtriCure's President and Chief Executive Officer. "We believe that the ABLATE clinical trial is another example of our unwavering commitment to build a great and enduring Company."
About AtriCure, Inc.
AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure Isolator(R) bipolar ablation system as a treatment alternative during open-heart surgical procedures to create lesions in cardiac tissue to block the abnormal electrical impulses that cause atrial fibrillation, or AF, a rapid, irregular quivering of the upper chambers of the heart. Additionally, medical journals and leading cardiothoracic surgeons have described the AtriCure Isolator(R) system as a promising treatment alternative for patients who may be candidates for sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke.
The FDA has cleared the AtriCure Isolator(R) bipolar ablation system, including the new Isolator Synergy(TM) ablation clamps and the AtriCure multifunctional bipolar Pen, for the ablation, or destruction, of cardiac tissue during surgical procedures. Additionally, the FDA has cleared the AtriCure Pen for temporary pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias. To date, the FDA has not cleared or approved AtriCure's products for the treatment of AF. AtriCure's left atrial appendage clip system has not been approved for commercial use. It is currently being used in clinical evaluations in Europe.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that address activities, events or developments that AtriCure expects, believes or anticipates will or may occur in the future, such as earnings estimates, other predictions of financial performance, launches by AtriCure of new products and market acceptance of AtriCure's products. Forward-looking statements are based on AtriCure's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances and are subject to numerous risks and uncertainties, many of which are beyond AtriCure's control. These risks and uncertainties include the rate and degree of market acceptance of AtriCure's products, AtriCure's ability to develop and market new and enhanced products, the timing of and ability to obtain and maintain regulatory clearances and approvals for its products, the timing of and ability to obtain reimbursement of procedures utilizing AtriCure's products, competition from existing and new products and procedures or AtriCure's ability to effectively react to other risks and uncertainties described from time to time in AtriCure's SEC filings, such as fluctuation of quarterly financial results, reliance on third party manufacturers and suppliers, litigation (including the purported class action lawsuit) or other proceedings, government regulation and stock price volatility. AtriCure does not guarantee any forward-looking statement, and actual results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
AtriCure, Inc.
http://www.atricure.com
AtriCure anunþã iniþierea de ABLATE pivot proces de evaluare a izolator de sinergie (tm) bipolar Ablation sistem pentru a trata fibrilaþie atrialã - AtriCure Announces Initiation Of The ABLATE Pivotal Trial To Evaluate The Isolator Synergy(TM) Bipolar Ablation System To Treat Atrial Fibrillation - articole medicale engleza - startsanatate