Abiomed’s Impella 2.5 and Impella 5.0 Heart Pumps Approved in Japan
September 27, 2016—Abiomed, Inc. announced that the company’s Impella 2.5 and Impella 5.0 heart pumps received Pharmaceuticals and Medical Devices Agency (PMDA) approval from the Japanese Ministry of Health, Labor & Welfare for the treatment of drug-resistant acute heart failure.
According to Abiomed, the percutaneous transcatheter temporary ventricular support devices that are approved in Japan for the indication of drug-resistant acute heart failure, such as cardiogenic shock, support systemic circulation by placing the device at the left ventricle through femoral artery access and expelling blood directly from the left ventricle to the ascending aorta. The Japanese indication states that the pump can be used for a duration determined by the physician based on the clinical needs of the patient.
A controlled rollout of the device in Japan will begin in the fourth quarter of the 2017 fiscal year, and postmarket surveillance on Impella usage will be conducted.
Abiomed advised that it is opening a larger office in Tokyo, recruiting for clinical support staff, and submitting for Japanese reimbursement in the near future. A rigorous onsite training and certification program is planned, including physician proctoring. Additionally, Abiomed is planning future discussions with the PMDA relating to potential regulatory reviews of the company’s Impella CP and Impella RP devices later this fiscal year.