First and Only System in the United States Approved to Treat Patients
with Persistent and Long-Standing Persistent Atrial Fibrillation
WEST CHESTER, Ohio, Dec 16, 2011 (BUSINESS WIRE) --AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in
cardiac surgical ablation systems and systems for the exclusion of the
left atrial appendage, today announced that the U.S. Food and Drug
Administration (FDA) has approved AtriCure's Synergy Ablation System for
the treatment of atrial fibrillation (AF). Specifically, the Synergy
Ablation System has been approved for the treatment of patients with
persistent and long-standing persistent AF during open-heart concomitant
coronary artery bypass grafting and/or valve replacement or repair
procedures. This is the first time a surgical ablation system has been
approved for the treatment of AF and the first time any system, catheter
or surgical, has been approved in the United States for the treatment of
patients with persistent and long-standing persistent AF.
"This marks the achievement of a major milestone for AtriCure, the field
of cardiac surgery, and the treatment of AF. The approval confirms the
effectiveness of the Synergy Ablation System and recognizes the
increasing need for the surgical treatment of AF," said David J.
Drachman, President and Chief Executive Officer. "We look forward to
educating physicians and patients on our surgical alternative for the
treatment of AF, which we believe will raise awareness for a large
number of AF patients that are currently being undertreated.
Importantly, we would like to thank all of our partners who worked with
us to achieve this approval, particularly the FDA, physicians and their
patients who participated in the ABLATE trial. Additionally, I would
like to recognize the efforts of the AtriCure team, who have worked
tirelessly toward the successful achievement of this seminal milestone."
The Synergy Ablation System includes AtriCure's Isolator Synergy clamps,
a radiofrequency generator and related switchbox. It was previously
cleared in the United States for cardiac tissue ablation during
concomitant open-heart surgical procedures.
The FDA's approval includes the implementation of a 350-patient
post-approval study, of which 46 patients have been enrolled through the
ABLATE AF study. Additionally, the FDA approval includes a physician
training program.
About AtriCure, Inc.
AtriCure,
Inc. is a medical device company and a leader in developing,
manufacturing and selling innovative cardiac surgical ablation systems
designed to create precise lesions, or scars, in cardiac, or heart,
tissue for the treatment of Atrial Fibrillation, or AF, and systems for
the exclusion of the left atrial appendage. The Company believes
cardiothoracic surgeons are adopting its ablation products for the
treatment of AF, during concomitant open-heart surgical procedures and
sole-therapy minimally invasive procedures. AF affects more than 5.5
million people worldwide and predisposes them to a five-fold increased
risk of stroke. AtriCure's Synergy Ablation system is cleared for the
treatment of patients with persistent and long-standing persistent AF
during open-heart concomitant coronary artery bypass grafting and/or
valve replacement or repair procedures. AtriCure's other products are
not approved in the United States for the treatment of other forms of AF
or for other uses for the treatment of AF. Additionally, the FDA has not
cleared or approved AtriCure's products for a reduction in the risk of
stroke.
Forward-Looking Statements
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.
SOURCE: AtriCure, Inc.
AtriCure, Inc.
Julie A. Piton, 513-755-4561
Vice President and Chief Financial Officer
jpiton@atricure.com
