WEST CHESTER, Ohio–(BUSINESS
WIRE)–AtriCure, Inc., 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 AtriCures 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 AtriCures 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 FDAs 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. AtriCures 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. AtriCures 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 AtriCures products for a reduction in the risk of stroke.
Posted by Sean Fenske, Editor-in-Chief, MDT
