AtriCure Announces Approval for the AtriClip in Japan

AtriCure Inc. 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/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/CEO of CMI.

The approval marks the first time 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 Sept. 30, 2015, sales of the AtriClip grew at a rate of 48 percent on a global basis as compared to the prior period in 2014.

Based in Mason, Ohio, AtriCure Inc. develops atrial fibrillation (Afib) solutions. 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, according to the company. 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. 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.