trending Market Intelligence /marketintelligence/en/news-insights/trending/jHyYiywpQj22Q3kVcHNP_g2 content esgSubNav
In This List

Abiomed's heart pump receives US FDA approval

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Abiomed's heart pump receives US FDA approval

Abiomed Inc. said the U.S. Food and Drug Administration approved the premarket application of Impella 5.5, a heart pump for patients experiencing cardiogenic shock.

Premarket applications, or PMAs, are submitted by manufacturers if a device or medical component is considered high risk and completely new to the market. PMAs take a longer time, cost more money in user fees and have stricter review procedures, usually requiring clinical data that are only required in some 510(k) reviews.

The device can pump more than six liters of blood into the heart and eliminates the need for sternotomy or coring of the heart's left ventricle. It is meant to be used for 14 days to treat cardiogenic shock in patients who have experienced a heart attack, open-heart surgery, heart muscle disease or heart muscle inflammation.

The device's SmartAssist feature integrates different data points including left ventricular pressure, end-diastolic pressure and cardiac power output. It also helps in the precise positioning of the pump.

The device received CE marking approval in Europe in April 2018 and will be rolled out in U.S. hospitals, the company said in a Sept. 25 press release.