Approval opens up a new market for the most widely implanted left
atrial appendage occlusion device in the world
WEST CHESTER, Ohio--(BUSINESS WIRE)--Jan. 19, 2016--
ATRC), a leading innovator in treatments for atrial fibrillation
(Afib) and left atrial appendage (LAA) management, today announced that
it has received approval from the Japanese Ministry of Health, Labor and
Welfare (MHLW) for its AtriClip™ products, which includes the AtriClip™
Standard and the AtriClip Pro™ devices.
“We are excited to bring the AtriClip to Japan,” said Mike Carrel,
President and CEO of AtriCure. “This is an important milestone for our
growth prospects in the Japanese market, and we are thrilled that we can
offer our LAA products to Japanese customers and patients. We see a
great opportunity in the Japanese market for this solution, and are
looking forward to the launch.”
The company’s distributor in Japan, Century Medical Inc. (CMI), worked
closely with the company to secure approval. In addition, CMI will be
working closely with the MHLW to secure healthcare insurance system
reimbursement for the AtriClip products. CMI is the company’s exclusive
distributor in Japan under an agreement that runs through 2019.
“We’re pleased to have secured this important approval. We expect that
with this leading technology we will be able to significantly help
Japanese patients in the area of LAA occlusion,” said Takahiko Motani,
president and CEO of CMI.
The approval marks the first time that these products will be available
in the Japanese market. The AtriClip is the fastest growing part of the
AtriCure product portfolio. Through the nine months ending September 30,
2015, sales of the AtriClip grew at a rate of 48% on a global basis as
compared to the prior period in 2014.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160119006351/en/
Source: AtriCure, Inc.
Director, Corporate Marketing and Communications
Andy Wade, 513-755-4564
Senior Vice President and
Chief Financial Officer