AtriCure Receives FDA Approval for Investigational Study to Evaluate Stroke
Prevention in Atrial Fibrillation
AtriClip™ Left Atrial Appendage Exclusion System to be Evaluated as
Alternative to Anti-Coagulation Therapy
WEST CHESTER, Ohio -- November 19, 2013
AtriCure, Inc. (Nasdaq: ATRC), a leading developer of solutions to treat
atrial fibrillation (Afib), today announced the Food and Drug Administration’s
(FDA) approval to begin enrollment in a clinical study of AtriCure’s AtriClip®
Left Atrial Appendage Exclusion System. The study will evaluate the use of the
AtriClip device to prevent stroke in patients with Afib.
The feasibility study will enroll Afib patients at seven medical centers
across the country. The study will focus on patients with risk factors that
place them at significant risk of stroke as well as substantial bleeding risks
that contraindicate them for anticoagulation therapy. Research suggests that
up to 40% of patients are unable to take oral anticoagulants due to excessive
risk of bleeding.^1
Patients with Afib have a 500 percent increased risk of stroke over the
general public.^2 Afib related strokes are associated with higher morbidity
and mortality than non-Afib related strokes.^3 Since the left atrial appendage
(LAA), a muscular pouch attached to the heart, has been found to be the source
of approximately 90% of thrombi in Afib patients evaluated after a confirmed
stroke, this study will focus on complete and permanent mechanical closure of
During the feasibility study, patients will undergo a minimally invasive
surgical procedure. Utilizing small incisions in the chest wall surgeons will
place the AtriClip device directly onto the base of the LAA while the heart is
still beating. Complete exclusion of the LAA is confirmed during the procedure
using echo graphic imaging. Three months following the procedure, a
computerized tomography (CT) scan will be performed to re-confirm complete and
permanent LAA exclusion on all patients.
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 and permanent exclusion of the LAA
was confirmed in 98.4% of patients by a three month post procedure CT scan
with zero complications or adverse events. Since launch, more than 25,000
AtriClips have been implanted worldwide.
“Managing high risk Afib patients requires balancing the risk of stroke
against the risk of major bleeding,” said Dr. Basel Ramlawi, a cardiothoracic
surgeon at Houston Methodist DeBakey Heart Center and the Principal
Investigator in the study. “This study is a major step toward developing the
clinical evidence necessary to establish a viable, safe and attractive
alternative to life-long anticoagulation in Afib patients that currently have
very limited options. This will have a favorable impact on patients and the
healthcare system overall.”
“The Stroke Feasibility IDE study is significant because it is the first of
its kind to focus entirely on a group of untreated and undertreated Afib
patients that may benefit the most from total and permanent exclusion of their
left atrial appendage,” said Michael Carrel, President and Chief Executive
Officer of AtriCure. “This study is one of three FDA trials that AtriCure is
currently running as part of our strategy to be the leader in developing
proven and effective solutions for the worldwide Afib epidemic.”
About AtriCure, Inc.
AtriCure, Inc. is a leading atrial fibrillation (Afib) solutions partner,
providing innovative products, industry education and clinical science
investment to reduce the economic and social burden of atrial fibrillation.
AtriCure’s Synergy Ablation System is the first and only device approved by
the Food and Drug Administration (FDA) for the treatment of Persistent and
Longstanding Persistent forms of Afib in patients undergoing certain open
heart procedures concomitantly (simultaneously). 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
prevention of Afib related complications such as stroke.
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, 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, 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 Sudlow M, Thomson R, Thwaites B, Rodgers H, Kenny RA. Prevalence of atrial
fibrillation and eligibility of anticoagulation in the community. The Lancet.
1998 Oct 10;352(9135):1167-71.
^2 Benjamin EJ, Chen PS, Bild DE, et al. Prevention of atrial fibrillation:
report from a national heart, lung, and blood institute workshop. Circulation.
2009 Feb 3; 119(4):606-18.
^3 Marini C, De Santis F, Sacco S, et al. Contribution of atrial fibrillation
to incidence and outcome of ischemic stroke: results from a population-based
study. Stroke. 2005 Jun;36(6):1115-9.
^4 Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac
surgical patients with atrial fibrillation. Annals of Thoracic Surgery. 1996
Rasor Marketing Communications
Becky Fickenworth, 513-793-1234
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