First U.S. clinical study to evaluate the safety of a novel
epicardial-based left atrial appendage closure device for stroke
prevention in atrial fibrillation patients.
WEST CHESTER, Ohio--(BUSINESS WIRE)--May 21, 2014--
ATRC), a leader in surgical solutions to treat atrial fibrillation
(Afib), today announced the first patient enrolled in a feasibility
study using the AtriClip® Left Atrial Appendage Exclusion System for
stroke reduction in Afib patients unable to take anticoagulation. Dr.
Marc Gerdisch, chief of cardiovascular and thoracic surgery at
Franciscan St. Francis Health in Indianapolis, Indiana, performed the
first procedure via a minimally invasive surgical approach.
“We have used the AtriClip device for our at-risk patients undergoing
open heart surgery since 2008, and it has performed exceptionally well,”
said Dr. Gerdisch. “With enrollment of this first stroke study patient,
we have begun the process of providing atrial fibrillation patients at
highest risk, the opportunity to eliminate the most common source of
Patients with Afib are five times more likely to suffer a stroke
compared with patients who have a normal heart rhythm. The higher risk
of Afib-related stroke is believed to be related to the pooling of blood
in a small muscular pouch within the left atria called the left atrial
appendage (LAA). In Afib patients, the LAA has been shown to be the
source of more than 90 percent of stroke-causing blood clots. 1
During Afib, blood flow out of the LAA is reduced, increasing the
likelihood of clot formation. In some cases these clots travel from the
heart to the brain blocking the blood supply. Afib-related strokes are
typically much more severe and disabling than non-Afib strokes due to
the size and location of clots.
Anticoagulant medications reduce the risk of stroke significantly
although they carry a risk of severe bleeding. Other patients may be
unable to maintain a therapeutic level of anticoagulation in their
systems. This study will enroll Afib patients contraindicated to
anticoagulation medication and as a result do not have a reasonable
alternative available. No LAA closure devices have been approved for
stroke prophylaxis in the United States to-date.
“Afib patients who are unable to take anticoagulation present a
conundrum for cardiologists,” according to Dr. J.D. Graham, the
referring cardiologist for this case. “We need a reliable method to
address their embolic risk, and the answer will come from controlled
trials like this.”
The Stroke Feasibility Study is being conducted under an Investigational
Device Exemption (IDE). The Food & Drug Administration (FDA) previously
cleared the AtriClip LAA Exclusion System for the occlusion of the left
atrial appendage, under direct visualization, in conjunction with other
open cardiac surgical procedures.
“This study is key to fulfilling our commitment to developing compelling
Afib solutions that decrease the social and economic burden of atrial
fibrillation,” said Mike Carrel, chief executive officer of AtriCure.
“We are enthusiastic that our first patient has been enrolled and that
we are moving forward with this landmark trial, as we strive to improve
the lives of patients with Afib.”
Stroke Feasibility Study
The feasibility study is a prospective, single-arm, multi-center study
for AtriClip Left Atrial Appendage Exclusion System delivered via a
minimally invasive surgical procedure on a beating heart. Complete
exclusion of the LAA is confirmed during the procedure using echo
graphic imaging. The study will be conducted at seven leading centers in
the United States, enrolling 30 patients.
The study objective is to evaluate the initial safety and efficacy of
the AtriClip for stroke prevention in patients with non-valvular atrial
fibrillation, in whom long-term oral anticoagulation therapy is
medically contraindicated. For more information on this clinical study
Pending the completion of this feasibility study, an IDE pivotal trial
would be pursued to expand this study where the clinical data will be
used to support a future indication for stroke prophylaxis in patients
contraindicated to oral anticoagulation therapy.
The AtriClip LAA Exclusion System is indicated for the occlusion of the
left atrial appendage, under direct visualization, in conjunction with
other open cardiac surgical procedures. AtriCure received FDA 510(k)
clearance for the AtriClip device in June 2010 based upon the successful
results of the EXCLUDE trial (#G080095). In this study, complete
exclusion of the LAA was confirmed in 98.4 percent of patients at three
months post procedure by a CT scan.
With more than 30,000 devices implanted, the AtriClip LAA Exclusion
System is the most widely implanted LAA exclusion device in the world.
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 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 (LAA) exclusion device is the most widely
implanted device for LAA management worldwide. The company believes
cardiothoracic surgeons are adopting its ablation and LAA management
devices for the treatment of Afib and reduction of Afib related
complications such as stroke. Afib affects more than 5.5 million people
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.
1 Manning WJ. Atrial
fibrillation, transesophageal echo, electrical cardioversion, and
anticoagulation. Clin Cardiol. 1995; 18: 58,114 .
Lloyd-Jones D, Adams RJ, Brown TM, et al. Heart
Disease and Stroke Statistics—2010 Update: a report from the American
Heart Association. Circulation. 2010;121:e91.
Coyne KS, Paramore C, Grandy S, Mercader M, Reynolds M, Zimetbaum
the direct costs of treating nonvalvular atrial fibrillation in the
United States. Value Health. 2006 Sep–Oct;9(5):348–56.
Source: AtriCure, Inc.
Troy May, Media Relations, 513-658-8839