AtriCure Announces First Patient Enrolled in Stroke Feasibility Study
First U.S. clinical study to evaluate the safety of a novel
epicardial-basedleft atrial appendage closure device for stroke prevention in
atrial fibrillation patients.
WEST CHESTER, Ohio -- May 21, 2014
AtriCure, Inc.(Nasdaq: 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 Afib-related strokes.”
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
“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
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 visit:
www.clinicaltrials.gov. (CP 2011-2)
Pending thecompletionof this feasibility study, an IDE pivotal trial would
be pursued toexpand 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. AtriCurereceivedFDA510(k) clearance for the
AtriClip device inJune 2010based 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 worldwide.
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.
^2 Lloyd-Jones D, Adams RJ, Brown TM, et al.Heart Disease and Stroke
Statistics—2010 Update: a report from the American Heart
^3 Coyne KS, Paramore C, Grandy S, Mercader M, Reynolds M, Zimetbaum
P.Assessing the direct costs of treating nonvalvular atrial fibrillation in
the United States.Value Health. 2006 Sep–Oct;9(5):348–56.
Troy May, Media Relations, 513-658-8839
Press spacebar to pause and continue. Press esc to stop.