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Jerkmate
https://www.medtechdive.com/news/johnson-jnj-impella-heart-pump-ACC-no-patient-benefit-2-trials/816332/
J&J’s Impella heart pump shows no patient benefit in 2 trials | MedTech Dive
Study investigators cautioned against routine use of the device in complex percutaneous coronary interventions and to treat heart attack patients who don’t...
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https://www.medtechdive.com/news/fda-posts-early-alert-for-safety-issue-with-impella-heart-pump-devices/813178/
FDA posts early alert for safety issue with Impella heart pump devices | MedTech Dive
The cassettes have an increased risk of purge leaks that can lead to the loss of hemodynamic support.
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https://www.medtechdive.com/news/JNJ-Abiomed-recall-cybersecurity-heart-pump-controller/802685/
Cybersecurity triggers another recall of J&J’s Impella heart pump controller | MedTech Dive
While no patients have been harmed, the FDA categorized the action as a Class I recall because of the potential for serious injury or death.
impella heart pumpmedtech divecybersecuritytriggersanother
https://www.medtechdive.com/news/renewed-calls-for-impella-rct-as-jama-details-bleeding-death-rate-findings/572072/
Renewed calls for Impella RCT as JAMA details bleeding, death rate findings | MedTech Dive
Abiomed has cast doubt on the registry-based study, though some cardiologists argue it supports “a more restrictive use” of the circulatory support device.
renewed callsdeath ratemedtech diveimpellarct