|AtriCure Receives FDA Approval For Pivotal Study to Enroll Non-Paroxysmal Afib Patients|
AtriCure will investigate a minimally invasive approach to treat patients with persistent or long-standing persistent atrial fibrillation who have failed antiarrhythmic drug therapy.
WEST CHESTER, Ohio--(BUSINESS WIRE) November 3, 2014-- AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments for atrial fibrillation (Afib) and left atrial appendage management (LAAM), today announced it has received approval for an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA) to begin enrollment in the Dual Epicardial and Endocardial Procedure (DEEP)clinical trial. The DEEP trial is a prospective, multicenter, single arm, pivotal study to evaluate patients with persistent or long-standing persistent atrial fibrillation. This is the first pivotal study of its kind in the United States.
The study is designed to evaluate the safety and efficacy of the DEEP approach in treating non-paroxysmal (also called persistent, long-standing persistent and permanent) atrial fibrillation. The DEEP approach utilizes the specialized skills of both the cardiac surgeon and electrophysiologist (EP) to treat more severe cases of Afib, such as non-paroxysmal, which historically have been the most difficult to treat.
In the DEEP study, the cardiac surgeon and EP work as a team to perform a minimally invasive epicardial (outside the heart) ablation and endocardial (inside the heart) catheter-based ablation. The primary effectiveness endpoint is freedom from Afib and freedom of Class I or III antiarrhythmic drug therapy. AtriCure has FDA approval to enroll 220 subjects at up to 25 sites in the U. S. and internationally.
“We are pleased to be moving into this next phase of a pivotal trial for DEEP,” said Mike Carrel, chief executive officer of AtriCure. “Our goal is to start the Institutional Review Board process with many of the leading institutions right away. We intend to have our first subject enrolled in early 2015, with completion of enrollment targeted for mid-2017.”
“AtriCure is embarking on this landmark trial which will bring electrophysiologists and cardiac surgeons together as a team in an effort to establish a new standard of care for patients presenting with persistent or long-standing persistent Afib, a significant risk factor for stroke,” said Dr. James L. Cox, Emeritus Evarts A. Graham Professor of Surgery at Washington University. “AtriCure is fortunate to have such a distinguished group of physicians to provide leadership for this important trial.”
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.
“We look forward to pioneering the multi-specialty approach where EPs will work more closely with cardiac surgeons in this dual surgical approach,” said Dr. Ellenbogen.
Atrial fibrillation is the most common type of arrhythmia and can cause blood clots, stroke, heart failure and other heart–related complications. A patient with Afib has a high risk of stroke because the irregular heartbeat allows blood to pool in the left atrial appendage (LAA) and form clots that can travel through the body and into the brain.
Atrial fibrillation patients who have failed antiarrhythmic drug therapy and 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 occlude the LAA with the AtriClip® LAA Exclusion System. Then about three months later, the patient will undergo an endocardial mapping and catheter ablation procedure performed by the EP.
“The DEEP procedure combines the expertise of both the EP and cardiac surgeon and seeks to set a new standard of care for Afib ablation therapy,” said Dr. Kasirajan.
“The DEEP procedure is an integrated and minimally-invasive approach to resistant atrial fibrillation combining the strengths of multi-specialty ablation techniques. I am excited about the DEEP trial and evaluating patients with non-paroxysmal Afib for whom the outcome of traditional endocardial ablation has been challenging,” said Dr. Khoynezhad.
More than 2.7 million Americans are living with Afib, a cardiac rhythm disorder that increases in prevalence with age. Afib is associated with a five-fold increased risk of stroke. It is responsible for nearly 100,000 deaths, and adds $26 billion in expense to the U.S. healthcare system, each year. 1
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.2
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, 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 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 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 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 January, C., Wann S., Alpert J., Calkins H., Cleveland J., Cigarroa J., Conti J., Ellinor P., “2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society.” Circulation. 2014 March.
2 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.