Abiomed Impella Granted Emergency Use Authorization to Treat COVID-19 Cardiac Symptoms
The Impella has received Emergency Use Authorization amidst the growing concern of cardiac damage in COVID-19 patients.

The FDA has granted Emergency Use Authorization to Abiomed for their left-sided Impella heart pumps. These pumps are used to support patients during heart failure and provide left ventricular unloading.

The long-term effects of COVID-19 are not yet well-understood. Initially, the most focus was placed on respiratory issues and lung damage, which were the most obvious symptoms in patients. The effects on other parts of the body have largely been less clear and may take more time to understand. As containing and treating the virus becomes more manageable after the initial shock, more opportunity arises to study its short and long-term effects on the body.

The Prevalence of Cardiac Damage in COVID-19 Patients

Heart damage has been increasingly reported in COVID-19 cases. One recent study had a sample of 100 patients who had recovered from their respiratory symptoms of COVID-19, and had a negative swab test to indicate recovery. They were compared to a healthy control group, as well as a group of patients who had similar risk factors as the recovered COVID-19 patient group. Participant cardiac symptoms were tested using MRI.

The COVID-19-recovered group was found to have cardiac involvement in 78% of the participants, and ongoing myocardial inflammation was present in 60% of the participants. In this group, pre-existing conditions, the severity of their previous infection, and the presence of cardiac symptoms did not appear to have an effect on whether the patient experienced myocardial inflammation.

Although this study does not have a large sample size, the results suggest that cardiac damage may be widespread among COVID-19 patients, regardless of if they experienced pronounced cardiac symptoms during their infection.

The Impella Device

Abiomed has developed a treatment method for those experiencing cardiac damage from COVID-19. Abiomed’s Impella device may be used along with extracorporeal membrane oxygenation (ECMO) therapy, which is used to treat lung failure, so that patients may receive care for their lung and heart issues concurrently.

The Impella can provide left ventricular unloading, and help treat myocardial inflammation, which current research suggests is one of the most common cardiac issues related to COVID-19.

This device has previously been approved for use in patients experiencing cardiogenic shock. It has also been granted EAU in the past to treat right ventricular failure. Now it is approved specifically to provide left ventricular unloading to support patients receiving ECMO.

Dr. Christian Bermudez, professor of surgery & surgical director of lung transplantation & ECMO at University of Pennsylvania, said:

“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO. The superior clinical outcomes from the combination of Impella and ECMO are likely the result of reducing the stress on the myocardium and work required of the left ventricle, also reducing secondary lung injury due to pulmonary congestion.”

Conclusion

The Impella may be instrumental in providing support to patients experiencing both lung and cardiac issues following COVID-19 infection. With their emergence of important products in the field of interventional cardiology, this will have effects on Abiomed’s place in the competitive market.

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Via: MassDevice, Cardiovascular News, Pharmaceutical Technology