J&J Impella ECP heart pump meets primary endpoint
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12 hours ago
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- Abiomed, a division of Johnson & Johnson (NYSE:JNJ) MedTech, said that an investigational device exemption (IDE) study of the Impella ECP transvalvular axial flow pump met its primary endpoint, a measure of MACCE (Major Adverse Cardiac and Cerebrovascular Events).
- At 30 days, the MAACE rate was 6.3%, a figure significantly below the pre-defined performance goal.
- Abiomed said that the results indicate the safety and efficacy of Impella ECI in high-risk percutaneous coronary intervention, which is used to unblock clogged arteries.
- Abiomed added that at a 9Fr size at insertion, the device is designed to be implanted and removed using small bore access and closure techniques. Impella ECP can then expand to 21Fr to provide circulatory support and left ventricular unloading.