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New EUA Places Abiomed Firmly in the COVID-19 Conversation Image Courtesy of Abiomed

New EUA Places Abiomed Firmly in the COVID-19 Conversation

Abiomed said it was granted Emergency Use Authorization for the Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism. The Danvers, MA-based company initially received FDA approval for the device in 2017.

Sometimes when the discussion of tackling the novel coronavirus comes up, the use of medical devices gets lost in the shuffle. Most of the conversation surrounding COVID-19 comes from either the promise of a vaccine or the expansion of tests.

Abiomed is adding to the conversation surrounding medtech’s potential contribution to the treatment of COVID-19 patients. Monday, the Danvers, MA-based company by receiving Emergency Use Authorization for a device to treat COVID-19 related right heart failure patients.

The Impella RP is a temporary heart pump that provides circulatory support for patients who develop right side ventricular failure and initially won FDA approval in 2017.

“In this case, FDA authorized emergency use of the Impella RP to unload the right ventricle of the heart and provide mechanical circulatory support, specifically for COVID-19 patients,” Shon Chakrabarti, MD of Abiomed’s Medical Office Team, told MD+DI. “[This] include[s] patients who have pulmonary embolism where a blood clot forms in the pulmonary artery or travels from another area of the body, causing the hemodynamic collapse of the right ventricle.”

Chakrabarti added, “what we’ve learned with COVID-19 … is that it’s not like a lot of the other respiratory viruses that have caused pandemics in the past. We definitely see a vascular effect. What we see is that it causes a prothrombotic environment in some patients. Some of these do get these pulmonary acute emboli and result in RV failure. There are a lot of really innovative physicians and interventional cardiologists that have used the right-sided device in these patients in the past.”

In a release, Abiomed said a 59-year-old Detroit-area woman diagnosed with COVID-19 benefited from Impella RP therapy. Amir Kaki, an interventional cardiologist and director of mechanical circulatory support at Ascension St. John Hospital in Detroit and his colleague, Dr. Ted Schreiber diagnosed her with an acute pulmonary embolism. After the clot was removed, the patient went into right ventricular failure and became hypotensive.

Drs. Schreiber and Kaki quickly placed an Impella RP and observed what they describe as a “dramatic and immediate” improvement in arterial pressure. Over the next five days, the Impella RP remained in place and the patient was monitored remotely using cloud-based Impella Connect technology. On the fifth day, Impella RP was removed.

Abiomed said the patient was later discharged home with her native heart. This case has been highlighted in the American College of Cardiology (ACC) educational programming on COVID-19.

Medtech is starting to play a more significant role in COVID-19. The story is currently moving beyond just pharmaceutical solutions and diagnostics.

Late last month, MD+DI compiled a list of medtech companies that were working on devices to centered around COVID-19. The list was curated from an April online pitch session hosted by MedTech Innovator in partnership with BARDA.

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