FDA approves Abiomed heart pump to treat coronavirus patients

Medical staff attend to a patient suffering from the coronavirus disease (COVID-19) in the Intensive Care Unit (ICU), at Scripps Mercy Hospital in Chula Vista, California, U.S., May 12, 2020.

Lucy Nicholson | Reuters

The Food and Drug Administration has approved the emergency use of Abiomed’s Impella heart pump to help treat Covid-19 patients suffering from heart and lung failure.

In 1 in 10 patients, the virus results in extreme inflammation of the heart, in addition to a build-up of fluid in the lungs. For 42-year-old Devan Smith, who had no history of heart disease, the combination proved nearly fatal in May.

“This wasn’t a heart attack in the traditional sense. It was a pure case of myocarditis,” or inflammation of the heart muscle, said Dr. John Finley, a cardiologist at Mercy Catholic Medical Center outside Philadelphia. “No sooner than we’d get him back to the ICU, that he arrested probably 10 to 15 times.” 

Doctors at Mercy had first put Smith on a ventilator, but when his heart began to fail they decided to try using Abiomed’s Impella heart pump to try to give his heart muscle a rest, in combination with an extracorporeal membrane oxygenation machine to pump more oxygen into his bloodstream. It’s a dual treatment normally used for high-risk cardiac patients.  

After five days, Smith was able to come off the machines and within a few weeks he had fully recovered.  

“It makes you look at life and appreciate life much better now, knowing that … two months ago, basically I would have died,” said Smith, who recently returned to his job as a warehouse worker in Philadelphia.

The Impella is not a new device, but it’s the first time it has received FDA approval of the emergency use for treating the heart in combination with an ECMO for coronavirus patients.

“It’s been around for a while because people have noticed that if a patient has to go on ECMO, sometimes the ECMO puts too much of a load on the heart,” said Dr. Charles Simonton, Abiomed chief medical officer, “but it does have a unique application for Covid, since there’s no other option like this for patients.”

Earlier this summer, the FDA authorized the emergency use of Abiomed’s Impella as a standalone treatment to stabilize Covid patients following the removal of pulmonary blood clots.

Smith was one of three patients who received the combination treatment in Pennsylvania this spring, and all three patients recovered. While Covid-19 patients often suffer continuing health issues after recovery, in Smith’s case there are no apparent physical after-effects.  

“His heart is normal, which is incredible. They even did a cardiac MRI to look for a scar or residual inflammation and it was normal,” as were his lungs and kidneys, said Finley.

“They saved my life!” Smith said. “A million times I say thank you!”

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