Abiomed Impella 2.5™and Impella 5.0™ Heart Pumps Receive Regulatory Approval From Japan Ministry of Health, Labor & Welfare

DANVERS, Mass., Abiomed, Inc. a leading provider of breakthrough heart support technologies, announced today that the 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 (MHLW) for the treatment of drug-resistant acute heart failure.

With this approval, these are the first and only percutaneous temporary ventricular support devices that are PMDA-approved in Japan deemed safe and effective in the indication, as stated:

This product is a catheter-styled blood pump, used for drug-resistant acute heart failure, such as cardiogenic shock, to support systemic circulation by placing the device at left ventricle from a femoral artery insertion and expelling blood directly from left ventricle to ascending aorta.

Acute heart failure is a sudden and temporary morbid state in which various factors such as acute myocardial infarction, ischemic heart disease and/or reduced cardiac function may prevent the delivery of oxygen to the heart and other vital organs, resulting in the rapid deterioration of heart function. In Japan, it is estimated that 50,000 acute heart failure patient opportunities exist in the country. In the United States, this patient population is included in the high risk urgent PCI and cardiogenic shock indications. 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.

Japanese researchers and physicians have studied hemodynamic science and heart recovery for decades and have been leaders in the field for high-risk revascularization in the cath lab. Due to cultural and quality of life expectations and an aging society, Japan is the second largest medical device market in the world. Percutaneous options for revascularization are preferred over sternotomy or heart transplant alternatives because of the cultural interest in treating patients minimally invasively. For chronic heart failure patients, implantable LVAD devices or heart transplant remain an option at very limited sites for patients that do not have the ability to achieve native heart recovery. 

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.

“This approval marks a significant milestone to provide Impella hemodynamic 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,” said Michael R. Minogue, President, Chairman and Chief Executive Officer of Abiomed. “We are pleased that the field of heart recovery with percutaneous heart pumps has begun in Japan.”

Source: Abiomed, Inc.