AtriCure’s AtriClip™ System Receives FDA 510(k) Clearance

  AtriCure’s AtriClip™ System Receives FDA 510(k) Clearance

Business Wire

WEST CHESTER, Ohio -- June 14, 2010

AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in
cardiac surgical ablation systems, today announced that it received clearance
from the FDA for its AtriClip Gillinov-Cosgrove Left Atrial Appendage
Exclusion system. The AtriClip system is designed to safely and effectively
exclude the left atrial appendage. Initial launch in the United States is
anticipated to begin later this month with full commercial release planned
during the third quarter of 2010.

“Clearance of the AtriClip system in the United States represents a major
product and clinical milestone for AtriCure,” said David J. Drachman,
President and Chief Executive Officer. “We believe that the AtriClip system
provides a safe and efficient method to exclude the left atrial appendage.
This key innovation represents a large and exciting new growth platform and
demonstrates our steadfast commitment to developing market leading
technologies to meet the needs of patients and physicians.”

About the Left Atrial Appendage and the AtriClip System

The AtriClip system includes a clip device that is designed to exclude the
left atrial appendage, a hollow sac-like structure attached to the heart’s
left atrium.The left atrial appendage has internal peaks and valleys, or
trabeculations. During AF, stagnant blood pools in the trabeculations of the
left atrial appendage and is known to form clots that can migrate to other
parts of the body. The AtriClip is designed to be implanted from the outside
of the heart, avoiding contact with circulating blood and eliminating blood
flow between the left atrial appendage and the atria. The AtriClip system has
been cleared by the FDA for occlusion of the left atrial appendage, under
direct visualization, in conjunction with other open-heart cardiac procedures.

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 and
systems for the exclusion of the left atrial appendage. Medical journals have
described the adoption by leading cardiothoracic surgeons of the AtriCure
Isolator^® 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 Isolator ^ system 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 Coolrail^TM 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 Cryo1 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.

Contact:

AtriCure, Inc.
Julie A. Piton, Vice President and Chief Financial Officer, 513-755-4561
jpiton@atricure.com
 
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