First 1,000 Patients Treated with Impella 5.5 with SmartAssist, a Heart Pump Designed for Surgeons

Abiomed (NASDAQ: ABMD) announces 1,000 patients have been treated with the Impella 5.5 with SmartAssist heart pump in the first year after the U.S. Food and Drug Administration (FDA) granted Impella 5.5 with SmartAssist its highest level of approval for safety and efficacy.

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The Impella 5.5 with SmartAssist heart pump helped Keith Brown, 64, recover from a heart attack. (Photo: Business Wire)

In October 2019, the first U.S. 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 U.S. 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. (see figure 1) Uses of Impella 5.5 with SmartAssist include:

• Escalating a patient’s care to a higher level of cardiac support
• Providing bi-ventricular support, when used in combination with Impella RP
• Unloading the left ventricle of patients on ECMO, a combination therapy known as ECpella

In July, a study published in the American Society for Artificial Internal Organs (ASAIO) Journal found 84% survival to explant for Impella 5.5 with SmartAssist patients in cardiogenic shock and other challenging cardiac conditions. 76% of those patients achieved native heart recovery.

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, MD, 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.”