AtriClip is the most widely used device globally for left atrial
WEST CHESTER, Ohio--(BUSINESS WIRE)--Apr. 21, 2015--
ATRC), a leading innovator in surgical treatments for atrial
fibrillation (Afib) and left atrial appendage management, today
announced it has sold more than 50,000 AtriClip® Left Atrial
Appendage Exclusion System devices worldwide, making it not only the
preferred surgical device but also the most widely used of all devices
for excluding the left atrial appendage (LAA), with more units sold than
all other LAA management devices combined.
The LAA is a muscular pouch attached to the heart’s left atrium. In
patients with Afib and other cardiac arrhythmias, blood can pool and
form clots in the appendage, which may then leave the heart and cause
strokes. One study concluded that more than 90 percent of detected blood
clots in patients with atrial fibrillation are formed in the LAA.1
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.1 Prior to the invention of the AtriClip system,
cardiac surgeons typically addressed the LAA during open heart surgery
by cutting it off or closing off the opening of LAA to the atrium. This
approach required extra time on the heart-lung machine and posed a risk
of hemorrhaging and or reopening over time.
“Cardiac Surgeons are increasingly becoming more comfortable with using
our device versus the traditional methods of amputation or simply
closing the opening with suture or stapling devices,” said Mike Carrel,
president and chief executive officer of AtriCure. “We are excited about
our prospects for continued significant growth.”
“From my experience, the AtriClip device has provided consistent LAA
closure every time,” said Dr. Andrea Natale, Electrophysiologist and
Executive Medical Director, Texas Cardiac Arrhythmia Institute at St.
David’s Medical Center. “I have been working more closely with my
cardiac surgeons and recommending that the AtriClip System be used for
The AtriClip System is cleared by the Food and Drug Administration with
an indication for occlusion of the left atrial appendage, under direct
visualization, in conjunction with other open cardiac surgical
procedures. The clearance resulted in part from the successful EXCLUDE
trial (NCT00779857), which showed the LAA was closed successfully with
the AtriClip device in 98.4 percent of patients, with no device-related
"The AtriClip provides surgeons with the speed, ease of delivery and
efficacy we need for LAA management," said Dr. Marc Gerdisch, Chief of
Cardiovascular and Thoracic Surgery, Franciscan St. Francis Health,
Indianapolis. "I have used the device for several years, including
minimally invasive procedures, and it has performed perfectly."
In early 2014, AtriCure initiated the Stroke Feasibility Study
(NCT01997905) using the AtriClip system in a minimally invasive
procedure on a beating heart in seven hospitals across the United
States. This study evaluates the safety of the AtriClip system when used
for stroke prevention in patients with non-valvular Afib who can’t take
long-term anticoagulation medications. Complete exclusion of the LAA
will be confirmed during the procedure using echo graphic imaging.
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.3 For
more information visit AtriCure.com
or follow us on Twitter @AtriCure.
1 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.
on file at AtriCure. IDE G080095, EXCLUDE study.
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.
Source: AtriCure, Inc.
Director, Corporate Marketing and Communications
Andy Wade, 513-755-4564
Senior Vice President and
Chief Financial Officer