Abiomed medical office completes review of observational analysis of impella presented at aha

Abiomed is committed to improving patient outcomes by performing fda studies and post-market surveillance, collecting real-world evidence and identifying and sharing best practices. impella is the most studied mechanical circulatory support device in the history of the fda with real-world clinical data on more than 110,000 patients in the impella quality (iq) database, fda randomized controlled trials (rct) and post-approval studies with greater than 5,000 patients, and more than 550 peer-reviewed publications. impella is proven to provide superior hemodynamic support over the intra-aortic balloon pump (iabp). the aha analysis is flawed because: the data source has significant limitations, containing just a fraction of impella patients and unable to delineate between common adverse events; the impella patients were much sicker and had greater baseline and procedural risks; the analysis excluded the costliest iabp patients who were escalated to other therapies. additionally, the conclusion is aggressive because administrative coding data cannot delineate between adverse events common to high-risk patients and device related events.
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