The collaborative study is the first international prospective
randomized multicenter study of its kind
AtriCure,
Inc. (Nasdaq:
ATRC), a leading innovator in treatments for atrial fibrillation
(Afib) and left atrial appendage management, today announced the first
patient has been enrolled in the CEASE (Combined
Endoscopic Epicardial
and Percutaneous)
AF clinical study.
The CEASE AF study will compare the results of a combined epicardial
surgical plus endocardial catheter technique versus a standard
endocardial catheter ablation technique for safety, efficacy and quality
of life for patients with persistent or long-standing persistent Afib.
In addition, the effects on economic measures of the two treatment
strategies will be evaluated. This will be the largest study of its kind
to date, covering over 200 patients, comparing interventional ablation
strategies in the setting of patients presenting with persistent AF with
enlarged left atrium (> 4 cm patients) and longstanding persistent AF,
which reflects a difficult to treat patient-subgroup.
“This is another significant milestone for AtriCure as we continue our
advancements in the fight against Afib,” said Michael Carrel, President
and Chief Executive Officer of AtriCure “This important study focuses on
a new standard of care for difficult to treat patients.”
The study is intended to increase the level of evidence for a combined
surgical plus catheter ablation approach as a therapy for the
stand-alone treatment Afib. Increasing levels of evidence will also
serve to support market access efforts in certain geographies, where
direct clinical evidence is often required for purposes of attaining
reimbursement. The first procedure was performed at the Sana Heart
Center Stuttgart, Germany by Prof. Dr. Kai-Nicolas Doll, M.D.
“This is the first international prospective randomized multicenter
study of its kind in these type of patients,” said Nicolas Doll, MD, and
Professor at Sana Heart Center in Stuttgart, Germany. “Until the CEASE
AF study, studies were mostly single site.”
This study hopes to prove that a hybrid approach that combines
epicardial surgical ablation with percutaneous catheter ablation in a
two-stage fashion, will provide superior clinical effectiveness through
a period of 36 months, when compared with repeated endocardial catheter
ablation in patients with the most severe forms of AF. This hypothesis
is supported by recent studies1,2, indicating that hybrid
ablation has higher success rates without the need for further
interventions.
“The team approach which involves electrophysiologists and surgeons
should have the potential to evolve into an effective treatment strategy
for difficult to treat AF patients.” According to Prof. Dr. Gerhard
Hindricks, University of Leipzig Heart Center, Germany.
The coordinating investigators for the CEASE AF trial are Prof. Dr.
Kai-Nicolas Doll, Sana Heart Center Stuttgart, Germany, and Prof. Dr.
Gerhard Hindricks, University of Leipzig Heart Center, Germany.
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.
-
Pison, L., La Meir, M., van Opstal, J., Blaauw, Y., Maessen, J.G.,
Crijns, H.J. Hybrid thoracoscopic surgical and transvenous catheter
ablation of atrial fibrillation. J Am Coll Cardiol, 2012, 60 (1),
54-61.
-
Muneretto C, Bisleri G, Bontempi L, Curnis A. Durable staged hybrid
ablation with thoracoscopic and percutaneous approach for treatment of
long-standing atrial fibrillation: A 30-month assessment with
continuous monitoring. J Thorac Cardiovasc Surg. 2012
Dec;144(6):1460-5.
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.
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