WEST CHESTER, Ohio, Feb 02, 2010 (BUSINESS WIRE) -- AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in
cardiac surgical ablation systems, today announced that it has executed
a definitive agreement with the Department of Justice (DOJ) and the
Office of Inspector General of the Department of Health and Human
Services to resolve the issues raised in the DOJ's investigation and the
related qui tam complaint regarding the marketing of the
Company's surgical ablation devices. The terms of the agreement are
substantially identical to those previously disclosed and specifically
state that AtriCure and its employees admit no wrongdoing or illegal
activity. The qui tam complaint will be formally dismissed when
the court approves the submission of the settlement papers and the
notice of dismissal that has been prepared by the DOJ.
David J. Drachman, President and Chief Executive Officer said, "Moving
forward, the men and women of AtriCure have never been more passionate
and committed to our mission of improving and preserving human life or
more confident in the power of our strategic plan. We believe strongly
that AtriCure is uniquely positioned to deliver results for patients,
physicians and shareholders."
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. Medical journals have described the adoption by leading
cardiothoracic surgeons of the AtriCure Isolator(R) bipolar
ablation system as a treatment alternative during open-heart surgical
procedures to create lesions in cardiac tissue to block the abnormal
electrical impulses that cause atrial fibrillation, or AF, a rapid,
irregular quivering of the upper chambers of the heart. Additionally,
medical journals and leading cardiothoracic surgeons have described the
AtriCure Isolatorsystem as a promising treatment alternative
for patients who may be candidates for 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. The FDA has
cleared the AtriCure Isolator system and AtriCure's multifunctional pen
and CoolrailTM linear ablation device, for the ablation, or
destruction, of cardiac tissue during surgical procedures. Additionally,
the FDA has cleared AtriCure's multifunctional pen for temporary pacing,
sensing, stimulating and recording during the evaluation of cardiac
arrhythmias and AtriCure's Cryo1TM system for the
cryosurgical treatment of cardiac arrhythmias. To date, the FDA has not
cleared or approved AtriCure's products for the treatment of AF.
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 (including the purported class
action lawsuits) 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
