5 August 2020 - - The United States Food and Drug Administration has issued an emergency use authorization for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis.

Impella is manufactured by Abiomed (NASDAQ: ABMD).

COVID-19 causes widespread inflammation which can result in damage to the lungs and heart. This damage may cause severe left ventricular dysfunction manifesting as pulmonary edema and/or myocarditis.

Impella combined with ECMO therapy (known as ECpella) has become an important tool for physicians treating COVID-19 patients suffering from both heart and lung failure.

Impella is the world's smallest heart pump. It first received FDA clearance in 2008 and FDA PMA approval as safe and effective in 2015.

During the last 10 years, Impella has provided left ventricular unloading to approximately 10,000 ECMO patients in cardiogenic shock. The FDA's EUA expands the use of Impella as an ECMO unloading therapy to include COVID-19 patients with pulmonary edema or myocarditis.

42-year-old Devan Smith, a warehouse worker from Pennsylvania who contracted COVID-19 in May, is an example of a patient who benefited from the unloading effect of Impella.

After contracting COVID-19, Devan became severely ill with severe myocarditis, multiorgan failure and respiratory failure.

Dr. John Finley, interventional cardiologist at Mercy Catholic Medical Center-Fitzgerald Campus in Darby, Pennsylvania, placed venous arterial ECMO to combat the respiratory effects of COVID-19 and placed Impella CP to unload Devan's heart and allow it to rest and recover.

After four days of support, Devan's heart showed dramatic improvement and he was weaned off Impella. The next morning, he was taken off ECMO support.

After three weeks in the hospital, Devan returned home with his native heart functioning normally. In July, he returned to work.

This is the second EUA the FDA has granted for Impella during the COVID-19 pandemic.

On May 29, 2020, the FDA issued an EUA to expand the use of Impella RP to include patients suffering from COVID-19-related right ventricular complications, including right ventricular dysfunction associated with pulmonary embolism.

Combined, the two EUAs authorize the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella RP for use in COVID-19 patients.

Impella is the only cardiovascular therapeutic device that has received FDA emergency use authorization to treat COVID-19 patients.

The Impella 2.5 and Impella CP devices are US FDA PMA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions such as stenting or balloon angioplasty, to reopen blocked coronary arteries.

The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist are US FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart.

The Impella RP is US FDA approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant or open-heart surgery.

The Impella RP is also authorized for emergency use by healthcare providers in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1.5 m2, for the treatment of acute right heart failure or decompensation caused by complications related to coronavirus disease 2019 (COVID-19), including pulmonary embolism.

The Impella RP has not been cleared or approved for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19.