AtriCure Receives FDA Clearance for New AtriClip® Device

MASON, Ohio–(BUSINESS WIRE)–AtriCure,
Inc. (Nasdaq:
ATRC), a leading innovator in treatments for atrial fibrillation
(Afib) and left atrial appendage management, today announced U.S. Food
and Drug Administration (FDA) 510(k) clearance for the AtriClip PRO2
Left Atrial Appendage (LAA) Exclusion System. The new AtriClip PRO2
system has increased functionality which enhances the capability to
occlude the LAA during minimally-invasive surgical (MIS) procedures.
“We are excited to receive FDA clearance for the AtriClip PRO2 device,”
said Michael Carrel, President and CEO of AtriCure. “The AtriClip
franchise is the fastest growing part of our business, and we are
committed to continued innovation to help our customers meet the needs
of their patients. The AtriClip PRO2 system has several advancements
that make it easier to use in MIS procedures.”
The AtriClip PRO2 system features an ambidextrous locking and
trigger-style clip closing mechanism, handle-based active articulation
levers, and a hoopless end effector. The ambidextrous locking and
trigger-style clip closing mechanism allows the operator to maintain
focus on the LAA while maneuvering the device. The handle-based active
articulation levers allow the operator to steer the end effector without
removing the device. The hoopless end effector enhances anatomical
visualization, and simplifies removal of the applier after deployment of
the clip.
“The AtriClip PRO2 system provides easier placement of the proven
AtriClip LAA occlusion technology,” said J. Michael Smith, MD at
TriHealth Heart Institute in Cincinnati. “The new deployment system
facilitates less invasive treatment of the LAA, including right chest
approaches in conjunction with valve replacement and cardiac ablation
procedures.”
AtriCure was the first company to receive FDA clearance for a device
designed specifically for occluding the LAA. Through the previous twelve
months ending December 31, 2015, sales of AtriClip products grew at a
rate of 45% on a global basis as compared to the prior period in 2014.
To date, AtriClip products have been used to treat more than 70,000
patients worldwide.
For more information about the AtriClip franchise or left atrial
appendage management visit our website at www.atricure.com/atrial-occlusion.
About AtriCure, Inc.
AtriCure, Inc. is a medical device company providing innovative atrial
fibrillation (Afib) solutions designed to produce 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 (LAA) 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 LAA management 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. Afib affects more than 33
million people worldwide. For more information visit
AtriCure.com or follow us on Twitter @AtriCure.