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Cardiologist's Fake Cancer; Gene Therapy Trial Resumes; More Impella Woes
Recent developments of interest in cardiovascular medicine ...
Impella devices have been the subjects of a series of Abiomed letters and FDA early alerts and recall notices. In January, Abiomed sent an urgent medical device correction about a malfunction risk ...
The FDA today issued a warning related to certain heart pump technologies made by Johnson & Johnson MedTech's Abiomed unit.
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 ...
Impella RP Post-Approval Study Data Presented at ACC 2019. Data demonstrates survival benefit with the Impella RP Recover Right protocol.
Abiomed has issued an urgent medical device correction for its Impella RP and Impella RP Flex series of heart pumps. In a letter sent to customers on January 27, Abiomed said the voluntary device ...
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 ...
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 ...
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