WEST CHESTER, Ohio--(BUSINESS WIRE)--AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage management, today announced the first patient has been enrolled in the CEASE (Combined Endoscopic Epicardial and Percutaneous) AF clinical study.
The CEASE AF study will compare the results of a combined epicardial surgical plus endocardial catheter technique versus a standard endocardial catheter ablation technique for safety, efficacy and quality of life for patients with persistent or long-standing persistent Afib. In addition, the effects on economic measures of the two treatment strategies will be evaluated. This will be the largest study of its kind to date, covering over 200 patients, comparing interventional ablation strategies in the setting of patients presenting with persistent AF with enlarged left atrium (> 4 cm patients) and longstanding persistent AF, which reflects a difficult to treat patient-subgroup.
“This is another significant milestone for AtriCure as we continue our advancements in the fight against Afib,” said Michael Carrel, President and Chief Executive Officer of AtriCure “This important study focuses on a new standard of care for difficult to treat patients.”
The study is intended to increase the level of evidence for a combined surgical plus catheter ablation approach as a therapy for the stand-alone treatment Afib. Increasing levels of evidence will also serve to support market access efforts in certain geographies, where direct clinical evidence is often required for purposes of attaining reimbursement. The first procedure was performed at the Sana Heart Center Stuttgart, Germany by Prof. Dr. Kai-Nicolas Doll, M.D.
“This is the first international prospective randomized multicenter study of its kind in these type of patients,” said Nicolas Doll, MD, and Professor at Sana Heart Center in Stuttgart, Germany. “Until the CEASE AF study, studies were mostly single site.”
This study hopes to prove that a hybrid approach that combines epicardial surgical ablation with percutaneous catheter ablation in a two-stage fashion, will provide superior clinical effectiveness through a period of 36 months, when compared with repeated endocardial catheter ablation in patients with the most severe forms of AF. This hypothesis is supported by recent studies1,2, indicating that hybrid ablation has higher success rates without the need for further interventions.
“The team approach which involves electrophysiologists and surgeons should have the potential to evolve into an effective treatment strategy for difficult to treat AF patients.” According to Prof. Dr. Gerhard Hindricks, University of Leipzig Heart Center, Germany.
The coordinating investigators for the CEASE AF trial are Prof. Dr. Kai-Nicolas Doll, Sana Heart Center Stuttgart, Germany, and Prof. Dr. Gerhard Hindricks, University of Leipzig Heart Center, Germany.
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. AtriCure recently acquired nContact, a leader in minimally invasive technology for epicardial ablation. nContact’s mission is to transform the underserved arrhythmia population through a multidisciplinary epicardial-endocardial ablation approach. Afib affects more than 33 million people worldwide. For more information visit AtriCure.com or follow us on Twitter @AtriCure.
- Pison, L., La Meir, M., van Opstal, J., Blaauw, Y., Maessen, J.G., Crijns, H.J. Hybrid thoracoscopic surgical and transvenous catheter ablation of atrial fibrillation. J Am Coll Cardiol, 2012, 60 (1), 54-61.
- Muneretto C, Bisleri G, Bontempi L, Curnis A. Durable staged hybrid ablation with thoracoscopic and percutaneous approach for treatment of long-standing atrial fibrillation: A 30-month assessment with continuous monitoring. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1460-5.
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.