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.
“I think the combined surgical-catheter ablation approach is a promising
treatment for atrial fibrillation,” said Dr. Wang. “That’s why I’m
really excited about being involved with this important study.”
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.
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 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.
Forward-Looking Statements
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.
Copyright Business Wire 2014