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AtriCure Completes Enrollment in Post Approval Study for the Synergy™ Ablation System

This is the largest study of its kind to evaluate surgical ablation for the treatment of chronic Afib

WEST CHESTER, Ohio--(BUSINESS WIRE)--Oct. 9, 2014-- AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments for atrial fibrillation (Afib) and left atrial appendage management (LAAM), today announced enrollment in the ABLATE Post Approval Study (PAS) is complete.

As of October 3, 2014, the ABLATE PAS enrolled 365 patients at 40 hospitals across the United States. AtriCure expects to release preliminary data from the study in about a year, with a complete report expected to be published in three years.

The ABLATE PAS evaluates clinical outcomes in patients with non-paroxysmal (persistent or longstanding persistent) forms of atrial fibrillation who were treated utilizing the AtriCure Synergy Ablation System to perform the Maze IV procedure. The non-paroxysmal Afib patient group represents about half of the diagnosed patient population and who are extremely challenging to manage with conventional medical therapy or catheter ablation.

“The PAS study is intended to build additional evidence of the safety, efficacy and long-term durability of the Maze IV concomitant treatment for Afib using AtriCure’s proprietary surgical devices,” said Dr. Patrick McCarthy, director of the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine and lead physician for the ABLATE PAS.

The AtriCure Synergy Ablation System is the first and only medical device to receive Food and Drug Administration (FDA) approval for the treatment of Afib in patients with persistent and long-standing persistent Afib undergoing coronary artery bypass grafting and/or valve replacement or repair.

The initial ABLATE study was completed prior to AtriCure receiving a Premarket Approval (PMA) for the Synergy Ablation System. This study reported results that showed 84 percent of patients free from Afib at six months following an open concomitant Maze IV treatment, and 75 percent of patients free from Afib and off of anti-arrhythmic pharmaceuticals at a mean follow-up of 22 months when assessed by 48-hour Holter monitors. The intent of the ABLATE PAS study is to demonstrate the positive results from the Maze IV treatment used in the original ABLATE study is reproducible and reliable when performed at hospitals across the country.

“We expect the post approval study will provide additional compelling evidence of the benefits of the AtriCure Synergy Ablation System and Maze IV procedure as a treatment for patients suffering from non-paroxysmal Afib,” said Mike Carrel, chief executive officer of AtriCure.

More than 2.7 million Americans are living with Afib, a cardiac rhythm disorder that increases in prevalence with age. Afib is responsible for nearly 100,000 deaths and adds $26 billion in expenses to the U.S. healthcare system each year. Afib is associated with a five-fold increased risk of stroke.1

About AtriCure

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 LAAM. 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 33.5 million people worldwide. 2 For more information visit. AtriCure.com or follow us on Twitter @AtriCure.

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.

Source: AtriCure, Inc.

AtriCure, Inc.
Troy May, 513-658-8839
tmay@atricure.com