Abiomed has announced that the first 1,000 patients have been treated with the Impella 5.5 with SmartAssist heart pump in the first year after the US Food and Drug Administration (FDA) granted approval for the device.
In October 2019, the first US patients were successfully treated by cardiac surgeons at Cleveland Clinic, Hackensack Meridian Health and Cedars-Sinai Medical Center. Since then, more than 120 hospitals in the USA and Europe have implanted the temporary heart pump.
The first 1,000 patients were treated primarily for cardiomyopathy, AMI cardiogenic shock, and post-cardiotomy cardiogenic shock, with an average duration of support of 14 days.
In August, the FDA granted Impella 5.5 with SmartAssist, and other left-side Impella heart pumps, an emergency use authorization (EUA) to treat certain patients with COVID-19 related complications who are undergoing ECMO treatment.
In October, the 2020 expert consensus from EACTS, ELSO, STS and AATS named Impella as a Class IIb recommendation as the primary or concomitant treatment option for post-cardiotomy cardiogenic shock with severe isolated left ventricular dysfunction. Impella is now recommended in 10 society clinical guidelines and consensus statements.
“We, as heart failure cardiologists and cardiac surgeons, are understanding the effectiveness of Impella 5.5 with SmartAssist as an unprecedented new option for cardiogenic shock patients as a bridge to recovery or bridge to next therapy,” said Shelley Hall, chief, transplant cardiology, MCS and heart failure at Baylor Scott and White Dallas. “This fully unloading device allows us to treat hemodynamically challenged patients faster and easier with improved outcomes. The Impella 5.5 with SmartAssist is contributing to saving lives and giving these critically ill patients a chance at survival.”
“The Impella 5.5 with SmartAssist is a promising option for heart failure patients in cardiogenic shock,” said Mani Daneshmand, director of heart & lung transplantation and mechanical circulatory support at Emory University Hospital. “A forward flow, minimally invasive heart pump gives surgeons an important new tool. With this heart pump, we have seen exceptional outcomes for our patients.”
The device is available in the USA and Europe for hospitals with established heart recovery protocols.