Abiomed has announced that its heart pumps Impella 2.5 and Impella 5.0 have received Pharmaceuticals and Medical Devices Agency (PMDA) approval from the Japanese Ministry of Health, Labor & Welfare (MHLW) for the treatment of drug-resistant acute heart failure. With this approval, according to a press release, these are the first and only percutaneous temporary ventricular support devices that are PMDA-approved in Japan deemed safe and effective in the indication.
The press release reports that the catheter-styled blood pumps are used for drug-resistant acute heart failure, such as cardiogenic shock, to support systemic circulation by being placed at left ventricle from a femoral artery insertion and expelling blood directly from left ventricle to 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.
“This approval marks a significant milestone to provide Impella haemodynamic support for heart failure patients. We commend the dedication of Japanese physicians and regulatory bodies in searching for new treatment options to improve patient outcomes and quality of life, and enable cost-effective solutions. We are pleased that the field of heart recovery with percutaneous heart pumps has begun in Japan,” Michael R Minogue, president, chairman and chief executive officer of Abiomed comments.
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. Additionally, the Company is planning future discussions with the PMDA relating to potential regulatory reviews of the Impella CP and Impella RP later this fiscal year.