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--
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
“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
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
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
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.
Troy May, 513-658-8839