Navigation Links
AtriCure Announces Initiation of the ABLATE Pivotal Trial to Evaluate the Isolator Synergy(TM) Bipolar Ablation System to Treat Atrial Fibrillation

WEST CHESTER, Ohio, Feb. 11 /PRNewswire-FirstCall/ -- AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in cardiac surgical ablation products, today announced that the first patient was successfully treated in AtriCure's ABLATE clinical trial. Dr. Richard Kaplon, a well-known cardiac surgeon, performed the procedure at Mercy General Hospital in Sacramento, California.

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.

Julie A. Piton

Vice President and Chief Financial Officer

(513) 755-4561

SOURCE AtriCure, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Boston Scientific Announces Start of Major European Registry Assessing Different Olimus-Eluting Stents
2. Genta Announces Common Stock Offering of Approximately $3.1 Million
3. Chakshu Research Announces Appointment of Dr. Randall Olson as Director
4. onTargetjobs Announces Acquisition of
5. Exelixis Announces February 14 Webcast of Its Fourth Quarter and Full Year 2007 Financial Results Conference Call
6. Schering-Plough Announces Organizational Changes at Schering-Plough Research Institute
7. Kosan Announces February 28, 2008 Conference Call and Webcast
8. InterMune Announces Fourth Quarter and Full Year 2007 Financial Results and Provides 2008 Guidance
9. Volcano Announces FDA 510(k) Clearance of Revolution Rotational Catheter and FFR for the s5i Integrated IVUS Console
10. Smart Genetics Announces Plans to Launch a New Alzheimers Risk Assessment Service
11. Bioponic Phytoceuticals Announces Record Sales Increase of 40% for the Month of January
Post Your Comments:
(Date:11/30/2015)... BETHESDA, Md. , Nov. 30, 2015 /PRNewswire/ ... property development company committed to the fostering and ... on the current and prospective initiatives designed to ... , Chief Executive Officer of Spherix. "Based on ... potential future licensees exceeds $50 billion and Spherix ...
(Date:11/30/2015)... 2015 Human Longevity, Inc. (HLI), the genomics-based, ... Cypher Genomics, Inc., a leading genome informatics company offering ... solutions. The San Diego -based company ... CEO and Co-founder, Ashley Van Zeeland , Ph.D., who ... details of the deal were not disclosed. ...
(Date:11/30/2015)... 30, 2015  Aytu BioScience, Inc. (OTCQB: AYTU), a ... conditions, will present at two upcoming investor conferences. Aytu ... real-time virtual conference, to be held December 3, 2015, ... be held December 2 nd & 3 rd ... and streamed live via webcast. Josh Disbrow ...
(Date:11/30/2015)... 30, 2015  Northwest Biotherapeutics (NASDAQ: NWBO ) ... immune therapies for solid tumor cancers, announced today that ... director, and the Company welcomes Neil Woodford,s ... recent anonymous internet report on NW Bio.  The Company,s ... Linda Powers stated, "We agree with Mr. Woodford ...
Breaking Biology Technology:
(Date:11/17/2015)... , November 17, 2015 Paris ... 2015.   --> Paris from 17 ... DERMALOG, the biometrics innovation leader, has invented the first ... fingerprints on the same scanning surface. Until now two different ... Now one scanner can capture both on the same ...
(Date:11/12/2015)... 12, 2015  A golden retriever that stayed healthy ... (DMD) has provided a new lead for treating this ... Broad Institute of MIT and Harvard and the University ... Cell, pinpoints a protective gene ... disease,s effects. The Boston Children,s lab of Lou ...
(Date:11/10/2015)... 2015 About signature verification ... to identify and verify the identity of an ... the secure and accurate method of authentication and ... individual because each individual,s signature is highly unique. ... dynamic signature of an individual is compared and ...
Breaking Biology News(10 mins):