AtriCure wins Japanese regulatory nod for AtriClip

AtriCure (NSDQ:ATRC) said today it won approval from the Japanese Ministry of Health, Labor and Welfare for its AtriClip line of products designed for the occlusion of the left atrial appendage.

The approval was achieved through the aid of the company’s Japanese distributor Century Medical Inc, the West Chester, Ohio-based company said.

“We are excited to bring the AtriClip to Japan. 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,” AtriCure CEO Mike Carrel said in prepared remarks.

Atricure said it will continue to work with CMI as it tries to secure healthcare insurance reimbursement for its AtriClip products in Japan.  Atricure and CMI have a distribution agreement that will run 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,” CMI CEO Takahiko Motani said in a press release.

Last month, Atricure launched a clinical trial comparing a combined ablation approach with catheter ablation in patients with persistent atrial fibrillation.

The 1st subject in the more-than-200-patient CEASE AF study was treated by co-principal investigator Dr. Nicolas Doll of the Sana Heart Center in Stuttgart, Germany, AtriCure said.

The trial is designed to compare a combination of surgical ablation of the heart’s outer epicardial layer and catheter ablation of the inner endocardial layer with standard endocardial catheter ablation in patients with enlarged left atria and long-standing, persistent AF over 3 years, the company said. It also aims to evaluate each technique’s economic effects, AtriCure said.

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