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Another One: Abiomed Wins 2nd EUA for Impella Related to COVID-19

The Danvers, MA-based company's EUA is specifically related to the Impella heart pumps providing left ventricular unloading and support COVID-19 patients.

Abiomed has been awarded a second Emergency Use Authorization for its Impella heart pump to help treat COVID-19 patients.

The Danvers, MA-based company's EUA is specifically related to the Impella heart pumps providing left ventricular unloading and support COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis.

In a release, Abiomed pointed out that the virus 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.

“The early clinical evidence continues to accrue in favor of including left ventricular unloading in many patients on ECMO,” Christian Bermudez, MD, surgical director, lung transplantation and ECMO, and professor of surgery at the University of Pennsylvania said in a release. “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.”

During Abiomed’s last recorded earnings call, the company’s CMO Seth Bilazarian, MD spoke to Impella’s potential when it came down to treating COVID-19 patients.  

“COVID-19 itself can affect the heart in a variety of ways and may directly affect the myocardium, causing myocarditis or via a hypercoagulable state presenting as an acute coronary syndrome, with clot resulting in myocardial infarction, or as a pulmonary embolism or critical limb ischemia or stroke,” Bilazarian said according to a Seeking Alpha transcript of the call.

Bilazarian added, “Impella has the potential to increase end-organ perfusion and reduced cardiac workload and shock related to these COVID-19 presentations, and they also stabilize patients, while anti-viral or anti-inflammatory therapies are deployed.”

Abiomed’s Impella first won FDA clearance in 2008 and the company won a PMA for the device in 2015. In late May, the company won its first EUA for Impella related to treating COVID-19  patients.  

 

TAGS: COVID-19
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