Abiomed: Approval received for Japan approval for its Impella 2.5 and Impella 5.0 heart pumps.

The approved devices are cannulas blood pumps, designed for acute heart failure (cardiogenic shock). Abiomed is opening a larger office in Tokyo, recruiting for clinical support staff, and submitting for Japanese reimbursement in the near future. A rigorous on-site training and certification program is planned including physician proctoring. Abiomed plans to start supporting patients in Japan during the fourth quarter of FY ’17 and will be investing in distribution, but does not expect material revenue until FY ‘18 given the controlled roll-out.

Abiomed plan to provide intensive care and support to the potential patients in Japan during the fourth quarter of fiscal 2017 with the latest product development. However, the approval is expected to prove accretive starting fiscal 2018.

Management is highly optimistic about the regulatory progress as it provides Impella hemodynamic support (an exclusive feature of the device) to heart failure patients, which is likely to fortify the company’s position in the heart pump markets.

Source: globenewswire