Abiomed’s Impella 5.5 With SmartAssist Approved in Japan, Hong Kong

Abiomed Inc. is expanding its Impella surgical product footprint worldwide.

The company recently gain approval from Japan’s Pharmaceuticals and Medical Devices Agency and Hong Kong’s Medical Device Division for the Impella 5.5 with SmartAssist, while the U.S. Food and Drug Administration (FDA) has granted an early feasibility study Investigational Device Exemption (IDE) to the Impella BTR (Bridge-to-Recovery). “The Japanese market is ideal for Impella 5.5 with SmartAssist because the technology provides minimally invasive, longer-term unloading support, enabling native heart recovery in a country that is more resistant to invasive sternotomies and heart transplants,” said Michael R. Minogue, Abiomed’s chairman, president and CEO. 

Impella 5.5 with SmartAssist is considered a game-changing technology for patients in Japan and Hong Kong. It is a minimally invasive, forward flow, fully unloading heart pump designed by and for heart surgeons with direct or axillary insertion. It received FDA post-market approval (PMA) two years ago and has been used since then to treat more than 4,000 U.S. patients for indications that include AMI cardiogenic shock, cardiomyopathy, and post-cardiotomy cardiogenic shock. Historically, the cardiogenic shock survival rate has been approximately 50 percent. Impella 5.5 with SmartAssist patients have a 74 percent survival to explant, with 59 percent of surviving patients achieving native heart recovery.
 
In Japan, Impella 5.5 with SmartAssist is now used to treat drug-resistant acute heart failure attributable to causes such as cardiogenic shock. The first Impella 5.5 with SmartAssist patient in Japan is expected to be treated in the coming months. 
 
The Impella BTR early feasibility IDE study clears the way for the first patient treatment with Impella BTR, a percutaneous heart pump with more than six liters of blood flow per minute. It is designed to be much less invasive than current LVADs. The Impella BTR development program aims to provide patients with home discharge and up to one year of full hemodynamic support. In the early feasibility study, 10 patients will be enrolled at up to five hospitals and supported by Impella BTR for up to 28 days. The first Impella BTR patient is expected to be treated in March or April this year.
 
“The FDA’s approval is a first step toward making this longer-term minimally invasive forward flow smart heart pump a reality for patients with chronic heart failure,” said Minogue.
 
Impella BTR is an investigational device, limited by U.S. law to investigational use only.
 
The Impella 2.5 and Impella CP devices are FDA-approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI), such as stenting or balloon angioplasty, 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 FDA-approved to treat heart attack or cardiomyopathy patients in cardiogenic shock and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.
 
Based in Danvers, Mass. Abiomed develops medical devices that provide circulatory support and oxygenation. Its products are designed to enable the heart to rest by improving blood flow and/or provide sufficient oxygenation to those in respiratory failure.