Danvers, Massachusetts-based Abiomed won FDA early feasibility study (EFS) investigational device exemption (IDE) for the Impella BTR (bridge-to-recovery), while the Impella 5.5 with SmartAssist won approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Hong Kong’s Medical Device Division (MDD).
The company designed the Impella BTR as a percutaneous heart pump with greater than six liters of blood flow per minute. Abiomed said in a news release that it designed Impella BTR to be much less invasive than current left ventricular assist devices (LVADs). Impella BTR is currently an investigational device limited by federal law to investigational use only.
Abiomed aims for the Impella BTR development program to provide a patient with a home discharge and up to one year of full hemodynamic support. The early feasibility study will include 10 patients enrolled at up to five hospitals to be supported by Impella BTR for up to 28 days. Abiomed expects the first Impella BTR patient to be treated in March or April of 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,” Abiomed Chairman, President & CEO Michael R. Minogue said in the release.
Impella 5.5 with SmartAssist is a minimally invasive, forward flow, fully unloading heart pump for heart surgeons with direct or axillary insertion. It garnered FDA post-market approval two years ago and has since been used to treat more than 4,000 U.S. patients for indications including AMI cardiogenic shock, cardiomyopathy and post-cardiotomy cardiogenic shock.
Approval in Japan indicates Impella 5.5 with SmartAssist for use in the treatment of drug-resistant acute heart failure attributable to causes such as cardiogenic shock. Abiomed expects the first patient use for the platform in Japan to occur in the coming months.
“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,” Minogue said.