AtriCure Enrolls First Patient in Randomized Multi-Center Trial Evaluating Post-Operative Afib

This study will evaluate the effects of excluding the LAA in cardiac
surgery patients at high risk of developing post-operative Afib

WEST CHESTER, Ohio–(BUSINESS WIRE)–AtriCure,
Inc.
(Nasdaq:
ATRC
), a leading innovator in treatments for atrial fibrillation
(Afib) and left atrial appendage management, announced today that the
first patient was enrolled and treated at PinnacleHealth Hospitals in
Harrisburg, Pennsylvania in the ATLAS (AtriClip®
Left Atrial Appendage
Exclusion Concomitant to Structural Heart
Procedures) clinical study. This observational study explores the use of
the AtriClip device to decrease complications associated with
post-operative Afib (POAF) by targeting specific cardiac surgery patient
populations at the highest risk of developing POAF.

Postoperative Afib occurs in up to 30% of patients undergoing cardiac
surgery.(1) Research has shown that specific risk factors
predict patients at greatest risk.(2) POAF is associated with
increased complications, increased reoperations and longer hospital
length of stay.(3) The ATLAS study will compare the clinical
impact of patients at highest risk of developing POAF to two randomized
treatment arms: surgical left atrial appendage (LAA) exclusion (using
AtriClip LAA Exclusion Systems) and patients with POAF and no surgical
LAA exclusion. In addition, the study will evaluate healthcare resource
utilization between the two groups.

“This is a very important study that will help us evaluate how left
atrial appendage management can improve care for cardiac surgery
patients,” said Michael Carrel, President and Chief Executive Officer
of AtriCure. “Studies have shown that the incidence of POAF in patients
undergoing cardiac surgery remains high in spite of numerous attempts to
drive this complication of surgery down. This study will help us
determine if a better care path exists for these at-risk patients with
the ultimate goal of improving patient care and decreasing healthcare
costs.(1)

This observational study will evaluate the thromboembolic and
hemorrhagic events of subjects diagnosed with POAF (AtriClip vs. no
AtriClip) through 365 days post index procedure. The study will enroll
up to 2,000 patients at 20 sites who are scheduled for cardiac surgery
with specific risk factors for developing new onset POAF as well as
significant risk factors for bleeding on commonly prescribed medications
to decrease the risk of Afib-related stroke.

“Clinical equipoise exists between effective LAA exclusion at the time
of cardiac surgery vs prophylactic anti-coagulation of POAF in patients
at elevated risk of major bleeding.” said Dr. Basel Ramlawi, Chairman
Heart and Vascular Center, Valley Health System/Winchester Medical
Center. “The ATLAS trial has the potential to directly impact clinical
practice for hundreds of thousands of cardiac surgical patients by
answering this question.”

“It is an honor and privilege for our team at Pinnacle to be part of
this highly important trial and enroll the first patient,” said Mubashir
Mumtaz, MD FACS FACC, Chief of Cardiovascular and Thoracic Surgery at
PinnacleHealth Hospitals, who performed the first procedure in the
study. “It demonstrates our partnership and commitment in understanding
the importance of left atrial appendage management in cardiac surgery
patients.”

About AtriCure

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. AtriCure recently acquired nContact, a leader in minimally
invasive technology for epicardial ablation. nContact’s mission is to
transform the underserved arrhythmia population through a
multidisciplinary epicardial-endocardial ablation approach. Afib affects
more than 33 million people worldwide. For more information
visit AtriCure.com or follow us on Twitter @AtriCure.

  1. Shen, J., Lall, S., Zheng, V., Buckley, P., Damiano, R., and
    Schuessler, R. The persistent problem of new-onset postoperative
    atrial fibrillation: A single-institution experience over two decades.
    The Journal of Thoracic and Cardiovascular Surgery, 2011, 141 (2),
    559-570.
  2. Steinberg, BA, et. al, Management of POAF and Subsequent Outcomes in
    Contemporary Patients Undergoing Cardiac Surgery: Insights from the
    CAPS-Care STS AF Registry. Clinical Cardiology, 2014 January; 37(1),
    doi:10.1002/clc.22230.
  3. Chua, SK, et al, Clinical Utility of CHADS2 and CHA2DS2-VASc scoring
    systems for predicting postoperative atrial fibrillation after cardiac
    surgery. The Journal of Thoracic and Cardiovascular Surgery,
    2013:146:919-26.

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 (including
projections and guidance), 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,
AtriCure’s ability to retain and attract key employees, 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, AtriCure’s ability to continue
to be in compliance with applicable U.S. federal and state and foreign
government laws and regulations, AtriCure’s ability to consummate
acquisitions or, if consummated, to successfully integrate acquired
businesses into AtriCure’s operations, AtriCure’s ability to recognize
the benefits of acquisitions, including potential synergies and cost
savings, failure of an acquisition or acquired company to achieve its
plans and objectives generally, risk that proposed or consummated
acquisitions may disrupt operations or pose difficulties in employee
retention or otherwise affect financial or operating results,
competition from existing and new products and procedures, including the
development of drug or catheter-based technologies, 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, fluctuations in exchange rates for future
sales denominated in foreign currency, which represent a majority of
AtriCure’s sales outside of the United States, 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. A further list and description of risks,
uncertainties and other matters can be found in our Annual Reports on
Form 10-K and Quarterly Reports on Form 10-Q.

Contacts

AtriCure, Inc.
Media Relations
Valerie Storch-Willhaus,
612-605-3311
Director, Corporate Marketing and Communications
vstorch-willhaus@atricure.com
or
Investor
Relations
Andy Wade, 513-755-4564
Senior Vice President and
Chief Financial Officer
awade@atricure.com