Abiomed received the US Food and Drug Administration (FDA) emergency use authorization (EUA) for Impella RP to treat patients suffering from Covid-19 related right heart failure or decompensation, including pulmonary embolism (PE).
Impella RP is a temporary heart pump designed to provide circulatory support for patients who develop right side ventricular failure. The safety and efficacy of Impella RP have been evaluated in five years pre- and post-market clinical studies.
The device has been approved by the FDA in 2017, for treating right ventricular failure in the setting of acute myocardial infarction and after cardiac surgery.
Impella RP can be rapidly deployed within minutes
The company said that its Impella RP has been a choice of therapeutic device for clinicians treating certain Covid-19 patients suffering right heart failure, since the onset of the Covid-19 pandemic.
In few patients, Covid-19 may create a prothrombotic environment resulting in acute pulmonary embolism, which leads to acute right ventricular failure.
Impella RP can be rapidly deployed within minutes, using a minimally invasive technique in the cardiac catheterisation laboratory or operating room, to treat critically ill patients.
Ascension St. John Hospital interventional cardiologist Amir Kaki said: “Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic.
“As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be life-saving.”
In December last year, Abiomed started the ST-elevation myocardial infarction door-to-unloading (STEMI DTU) pivotal randomised controlled trial (RCT) to further demonstrate the safety and effectiveness of Impella heart pump.
