Abiomed’s (NASDAQ: ABMD) newest right heart pump, the Impella RP with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) as safe and effective to treat acute ...

Impella RP Post-Approval Study Data Presented at ACC 2019. Data demonstrates survival benefit with the Impella RP Recover Right protocol.

The Impella RP platform includes the world’s smallest percutaneous right heart mechanical circulatory support (MCS) technologies designed to help patients achieve native heart recovery. They do not ...

The US Food and Drug Administration has confirmed that patients treated with Abiomed’s Impella RP system had a lower survival rate in a postapproval study than did those treated in preapproval ...

ABIOMED Inc.’s ABMD Impella RP recently attained the FDA’s Emergency Use Authorization (EUA) for treating COVID-19-related right heart failure or decompensation, including pulmonary embolism (PE).

After Abiomed’s attempts to expand the user pool for its Impella RP heart pump were less than successful, the FDA has updated the wording of the device’s label to direct it toward only the patients ...

The US Food and Drug Administration issued an updated letter to healthcare providers to disclose interim results from a post-approval study (PAS) of Abiomed Impella RP heart pump system. "These latest ...

WASHINGTON -- Abiomed Inc., a leading provider of breakthrough heart support technologies, today announced clinical trial results from RECOVER RIGHT, an Investigational Device Exemption (IDE) study of ...

Abiomed has voluntarily recalled the labeling for one model of its Impella circulatory assist pumps because it doesn't "appropriately address" certain safety issues, the US Food and Drug ...

Impella RP with SmartAssist is an innovative advancement of Impella RP, which was granted a PMA by the FDA in 2017 and has treated thousands of patients globally with right heart failure or ...