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Impella 5.5 with SmartAssist is now approved for use in Japan and Hong Kong. (Graphic: Business Wire)
Regulatory Authorities Authorize Impella 5.5 Pump with SmartAssist in Japan and Hong Kong as U.S. FDA Grant Conditional Experimental Device Exemption to Impella BTR in First Human Early Feasibility Study
Regulators in three countries have granted authorizations for Impella surgical products, as Abiomed (NASDAQ: ABMD) continues to execute its strategy of sustainable growth through new products, new indications and a presence in new areas geographic. In the United States, the Food and Drug Administration (FDA) granted an investigational device exemption (IDE) to Impella BTR (Bridge-to-Recovery) as part of an early feasibility study. In Asia, the Impella 5.5 pump with SmartAssist has been approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) and the Medical Device Division (MDD) of Hong Kong.
Impella 5.5 with SmartAssist is game-changing technology for patients in Japan and Hong Kong. It is a minimally invasive, forward flow, full discharge, direct or axillary insertion heart pump that was designed by and for cardiac surgeons. The FDA granted it post-marketing authorization (PMA) two years ago. Since then, the pump has been used to treat over 4,000 US patients who have, for example, suffered cardiogenic shock from AMI, post-cardiotomy cardiogenic shock, or with cardiomyopathy. The cardiogenic shock survival rate has historically been close to 50%. Patients treated with the Impella 5.5 device with SmartAssist benefit from a 74% survival rate at explant. Recovery of the native heart is observed in 59% of surviving patients.
In Japan, the Impella 5.5 pump with SmartAssist is now indicated to treat acute drug-resistant heart failure attributable to causes such as cardiogenic shock. The Impella 5.5 device with SmartAssist is expected to be used for the first time on a Japanese patient in the coming months.
“The Japanese market is ideal for the Impella 5.5 with SmartAssist, because this technology allows for minimal invasion assistance, longer-term discharge, as well as recovery of native heart function in a country where sternotomies and transplants occur. cardiac invasives are not as well accepted, ”said Michael R. Minogue, Chairman and CEO of Abiomed.
In the United States, the FDA cleared the early feasibility study with an IDE for Impella BTR, which paves the way for the treatment of one patient with this world-first device. The Impella BTR is a percutaneous heart pump capable of delivering blood in excess of six liters per minute. It was designed to be much less invasive than current left ventricular assist devices (LVAD).
The vision of the Impella BTR development program is to enable patients to return home and receive full hemodynamic support for a period of up to one year. As part of the early feasibility study, ten patients will be recruited from up to five hospitals to use Impella BTR for up to 28 days. A patient’s first treatment with Impella BTR is expected to take place in March or April of this year.
“FDA clearance is a first step in the process of making this smart, forward-flow, minimally invasive heart pump a reality for patients with chronic heart failure,” says Mr. Minogue.
The Impella BTR pump is an experimental device restricted to this single use by federal legislation.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5® and Impella CP® devices have been approved by the US FDA to treat certain patients with advanced heart failure who are undergoing urgent or elective percutaneous coronary interventions (PCI), such as stenting or angioplasty. balloon, to reopen blocked coronary arteries.
Impella 2.5, Impella CP, Impella CP with SmartAssist®, Impella 5.0®, Impella LD® and Impella 5.5® with SmartAssist® are heart pumps approved by the US FDA to treat patients with heart attacks or with cardiomyopathy and in cardiogenic shock. Their unique feature is that they make it possible to recover native heart function, allowing patients to go home with their own hearts.
The Impella BTR® pump is an experimental device restricted to this single use by federal legislation.
ABOUT ABIOMED
Based in the US city of Danvers, Massachusetts, Abiomed Inc. is a leading supplier of medical oxygenation and circulatory support devices. Our products are designed to allow the heart to rest by improving blood circulation and / or providing sufficient oxygen to people with respiratory failure. For more information, please visit www.abiomed.com.
FORWARD-LOOKING STATEMENTS
Any forward-looking statement is subject to risks and uncertainties such as those described in the periodic reports filed by Abiomed with the Securities and Exchange Commission. Actual results are likely to differ significantly from expected results.
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