WEST CHESTER, Ohio--(BUSINESS WIRE)--AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in technologies for the surgical treatment of atrial fibrillation (Afib) and left atrial appendage management, today announced the first two patients have been enrolled and treated at PinnacleHealth CardioVascular Institute in Harrisburg, Pennsylvania, in the Dual Epicardial and Endocardial Procedure (DEEP) clinical study. The pivotal study is the first of its kind in the United States for the treatment of persistent or longstanding persistent forms of Afib.
“This important study utilizes the skills of both the cardiac surgeon and electrophysiologist to establish a new standard of care for patients with persistent forms of Afib,” said Mike Carrel, President and Chief Executive Officer of AtriCure. “This is a significant milestone for AtriCure as we continue our advancements in the fight against Afib.”
In the DEEP study, the cardiac surgeon and electrophysiologist work as a team to perform a minimally invasive epicardial (outside the heart) surgical ablation and endocardial (inside the heart) catheter-based ablation. The primary effectiveness endpoint of the study is freedom from Afib, the most common arrhythmia, and absence of Class I or III antiarrhythmic drug therapy. AtriCure received approval in November 2014 from the U.S. Food and Drug Administration to enroll 220 patients at 25 sites in the DEEP study.
Atrial fibrillation patients who have failed antiarrhythmic drug therapy and may have received up to two failed catheter ablations are candidates for the DEEP study, which is performed in two phases. In the first phase, the surgeon will make small incisions to perform endoscopic epicardial ablation using the AtriCure Bipolar System, and exclude the left atrial appendage (LAA) with the AtriClip® LAA Exclusion System.
The first procedure in the study was performed by Dr. Mubashir Mumtaz, Chief of Cardiovascular and Thoracic Surgery at PinnacleHealth.
"We feel privileged to be part of this landmark study in our quest to find a safe and reliable treatment for millions of people affected by atrial fibrillation,” said Dr. Mumtaz. “We really believe that this trial will provide much needed insight into this disease. We are excited and feel honored to be able to enroll and treat the first two patients to kick off the trial."
The second phase of the procedure, catheter ablation and endocardial mapping, will be performed by Dr. Michael G. Link, Electrophysiologist at PinnacleHealth about 90 to 120 days after the surgical procedure.
“I am excited about DEEP because the more persistent forms of atrial fibrillation have been historically difficult to treat, with disappointing results,” said Dr. Link. “I am honored to be at the forefront of this trial which will hopefully alter the standard of care for these patients."
The principal investigators for DEEP are Dr. Kenneth Ellenbogen, Chairman of the Division of Cardiology at Virginia Commonwealth University (VCU) Pauley Heart Center; Dr. Paul Wang, Director, Stanford Arrhythmia Service, Professor of Medicine and Bioengineering, by courtesy, Stanford University School of Medicine; Dr. Vigneshwar Kasirajan, Chairman, Department of Surgery and Division of Cardiothoracic Surgery and Professor, Department of Surgery at VCU Pauley Heart Center; and Dr. Ali Khoynezhad, Professor of Cardiovascular Surgery at Cedars-Sinai Heart Institute.
More information can be found at www.AtriCure.com.
AtriCure, Inc. is a medical device company providing innovative atrial fibrillation (Afib) solutions designed to produce superior outcomes that reduce the economic and social burden of atrial fibrillation. AtriCure’s Synergy™ Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure’s AtriClip left atrial appendage management (LAAM) exclusion device is the most widely sold device worldwide that’s indicated for the occlusion of the left atrial appendage. The company believes cardiothoracic surgeons are adopting its ablation and LAAM devices for the treatment of Afib and reduction of Afib related complications such as stroke. Afib affects more than 33 million people worldwide.1 For more information visit AtriCure.com or follow us on Twitter @AtriCure.
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 (including projections and guidance), 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, AtriCure’s ability to retain and attract key employees, 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, AtriCure’s ability to continue to be in compliance with applicable U.S. federal and state and foreign government laws and regulations, AtriCure’s ability to consummate acquisitions or, if consummated, to successfully integrate acquired businesses into AtriCure’s operations, AtriCure’s ability to recognize the benefits of acquisitions, including potential synergies and cost savings, failure of an acquisition or acquired company to achieve its plans and objectives generally, risk that proposed or consummated acquisitions may disrupt operations or pose difficulties in employee retention or otherwise affect financial or operating results, competition from existing and new products and procedures, including the development of drug or catheter-based technologies, 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, fluctuations in exchange rates for future sales denominated in foreign currency, which represent a majority of AtriCure’s sales outside of the United States, reliance on third party manufacturers and suppliers, litigation 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. A further list and description of risks, uncertainties and other matters can be found in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q.
1 Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, et al., “Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study.” Circulation. 2014 Feb 25; 129 (8):837-47.