Increased shaft flexibility allows a surgeon more maneuverability
within a patient’s unique anatomy when excluding the left atrial
WEST CHESTER, Ohio--(BUSINESS WIRE)--Sep. 18, 2014--
ATRC), a leading innovator in surgical treatments for atrial
fibrillation (Afib) and Left Atrial Appendage Management (LAAM), today
announced the introduction of the AtriClip® FLEX, a new
device with a more flexible aluminum shaft that allows surgeons to
better maneuver within a patient’s particular anatomy.
The device is one of four products within the AtriClip Left Atrial
Appendage Exclusion System portfolio used in patients who suffer with
Afib. The AtriClip FLEX device is currently available in the United
States, with availability in Europe and other geographies coming later
The AtriClip is utilized by cardiac surgeons to occlude the left atrial
appendage, a small muscular pouch attached to the left atrium of the
heart. Since research indicates more than 90 percent of blood clots
develop in the LAAM in Afib patients1, surgeons often exclude
the appendage to prevent clot formation. AtriClip is the most widely
used LAAM occlusion device with more than 35,000 sold worldwide since
its introduction to the market in 2010.
“The introduction of the new AtriClip FLEX with the malleable
deployment tool shows AtriCure's commitment to constant improvement, to
patients, and to the physicians who treat them on a daily basis,” said
Dr. Theodore S. Wright, cardiothoracic surgeon at Gill Heart Institute,
University of Kentucky HealthCare who was the first surgeon to use the
AtriClip FLEX device.
AtriClip has a Food and Drug Administration indication for the occlusion
of the LAAM under direct visualization, in conjunction with other open
cardiac surgical procedures. The LAAM Exclusion System portfolio
includes the AtriClip PRO, AtriClip long and AtriClip standard, which
have different lengths and deployment features.
“AtriCure is dedicated to developing medical devices that solve complex
problems and improve the lives of patients,” said Mike Carrel, chief
executive officer of AtriCure. “AtriClip FLEX is a good example of how
we listen and respond to the unique needs of surgeons.”
Patients who suffer from Afib have a 500 percent greater risk of stroke,
compared with the general population.2 Afib-related strokes
are associated with higher morbidity and mortality than non-Afib related
strokes.3 More than 5.2 million people in the United States4,
and more than 33 million people worldwide5, suffer with
In early 2014, AtriCure initiated the Stroke Feasibility Study
(NCT01997905) using the AtriClip System in a minimally invasive
procedure on a beating heart. This study will evaluate the safety of the
AtriClip System when used for stroke prevention in patients with
non-valvular atrial fibrillation who can’t take long-term
anticoagulation medications. Complete exclusion of the LAAM will be
confirmed during the procedure using echo graphic imaging. The study
will be conducted at seven hospitals in the United States, enrolling up
to 30 patients.
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. 5
1. Jeff S. Healey, MD, Eugene Crystal, MD, Andrew Lamy, et
al. “Left Atrial Appendage Occlusion Study (LAAOS): Results of a
randomized controlled pilot study of left atrial appendage occlusion
during coronary bypass surgery in patients at risk for stroke.” American
Heart Journal. 2005 Aug; 150:288-93.
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.
X, et al. “Estimates of current and future incidence and
prevalence of atrial fibrillation in the U.S. adult population.” American
Journal of Cardiology. 2013 Oct. 15; 112 (8):1142-7.
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