FDA approves Abiomed heart pump to treat patients with Covid-19


The Food and Drug Administration has approved the emergency use of Abiomed’s Impella heart pump to help treat Covid-19 patients with heart and lung failure, the company said on Tuesday.In 1 in 10 people, the virus causes extreme inflammation of the heart, in addition to a buildup of fluid in the lungs. For Devan Smith, 42, who had no history of heart disease, the combination proved almost fatal in May.

“It 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 of Philadelphia. “We’d hardly get him back to the ICU, which he’s probably arrested 10 to 15 times. ”

Mercy’s doctors first put Smith on a ventilator, but when his heart started failing, they decided to try using Abiomed’s Impella heart pump to try and give his heart muscle a rest, by combination with an extracorporeal membrane oxygenation machine to pump more oxygen into his bloodstream. It is a dual treatment normally used for high risk heart patients.

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

“It makes you look at life and appreciate it a lot better now, knowing that… two months ago I’d be basically dead,” said Smith, who recently returned to his job as a storekeeper in Philadelphia.

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

“This has been around for a while because people have noticed that if a patient has to have ECMO, sometimes the ECMO puts too much of a load on the heart,” said Dr Charles Simonton, Chief Medical Officer of Abiomed, “ but it does. have a unique app for Covid, as there is no other option like this for patients. ”

Earlier this summer, the FDA cleared the emergency use of Abiomed’s Impella as a stand-alone treatment to stabilize Covid patients after pulmonary blood clots have cleared.

Smith was one of three patients who received the combination treatment in Pennsylvania this spring, and all three patients have recovered. While patients with Covid-19 often suffer from persistent health issues after they recover, in Smith’s case there are no apparent physical sequelae.

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

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


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