Abiomed’s Impella receives FDA Emergency Use Authorization during Covid-19 pandemic

On 4 August, Abiomed announced that the FDA had issued an Emergency Use Authorization (EUA) for their left-sided Impella heart pumps to provide left ventricular unloading and support to Covid-19 patients undergoing ECMO treatment and develop pulmonary oedema or myocarditis.

As the Covid-19 pandemic continues, healthcare researchers and professionals are continuing to better understand the effects of the viral infection on the body. Since the early days of the pandemic, it has been well understood that the SARS-CoV-2 virus may cause damage to the lungs of patients who contract the virus.

However, its effects on other parts of the body are becoming more and more apparent as larger numbers of people contract the virus. Notably, damage to the heart has been reported in some cases of Covid-19.

In an effort to combat heart damage caused by SARS-CoV-2 such as myocarditis (inflammation of the heart tissue), Abiomed has pioneered a novel therapeutic option using its Impella device.

The Impella is a percutaneous heart pump that provides left ventricular unloading and support to the heart during heart failure. The Impella received FDA pre-market authorisation in 2015 and has since been increasingly used in clinical settings as an alternative to more invasive left ventricular assist devices (LVADs).

In Covid-19 patients, the Impella can be used alongside extracorporeal membrane oxygenation (ECMO) therapy—coined “ECpella” therapy—to simultaneously treat both heart and lung failure in these patients.

Though the Impella device has been used to provide left ventricular unloading support to patients on ECMO therapy in cardiogenic shock for many years, the EUA now allows the device to be used for Covid-19 patients receiving ECMO therapy who need left ventricular unloading support due to pulmonary oedema or myocarditis.

This is the second EUA provided to one of Abiomed’s Impella devices during the Covid-19 pandemic; in May, the FDA issued an EUA for the Impella RP to treat Covid-19 patients suffering from right heart failure.

According to Abiomed’s press release, the Impella device is the only cardiovascular device to receive an EUA from the FDA during the Covid-19 pandemic, highlighting its importance in fighting the complications of Covid-19 infection.

The hemodynamic support market had been growing in value prior to the Covid-19 pandemic; GlobalData estimated the US market value for percutaneous ventricular assist devices to be just over $800m in 2019. The market for these devices dropped significantly in Q1 and Q2 of 2020 due to the pandemic.

As Covid-19 case numbers now surge again in some regions of the US, GlobalData predicts that this additional FDA EUA for the Impella device will help to increase revenue for Abiomed going forward, as a larger number of Covid-19 patients can now be treated using the Impella devices.