{"id":49873,"date":"2022-10-20T17:03:01","date_gmt":"2022-10-20T15:03:01","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/abiomed-successfully-completes-all-impella-post-approval-studies-for-high-risk-pci-cardiogenic-shock-post-cardiotomy-cardiogenic-shock-and-right-heart-failure\/"},"modified":"2022-10-20T17:03:01","modified_gmt":"2022-10-20T15:03:01","slug":"abiomed-successfully-completes-all-impella-post-approval-studies-for-high-risk-pci-cardiogenic-shock-post-cardiotomy-cardiogenic-shock-and-right-heart-failure","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/abiomed-successfully-completes-all-impella-post-approval-studies-for-high-risk-pci-cardiogenic-shock-post-cardiotomy-cardiogenic-shock-and-right-heart-failure\/","title":{"rendered":"Abiomed Successfully Completes All Impella Post-Approval Studies for High-Risk PCI, Cardiogenic Shock, Post-Cardiotomy Cardiogenic Shock and Right Heart Failure"},"content":{"rendered":"
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DANVERS, Mass.–(BUSINESS WIRE)–Abiomed<\/a> (Nasdaq: ABMD) announces the U.S. Food and Drug Administration (FDA) has accepted and closed the post-approval study reports related to the pre-market approvals (PMA) for Impella heart pumps<\/a>. The FDA\u2019s action is another affirmation that Impella heart pumps are safe and effective for cardiogenic shock, high-risk PCI, post-cardiotomy cardiogenic shock, cardiogenic shock in the setting of myocarditis or cardiomyopathy, and right heart failure.\n<\/p>\n

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\nThe FDA typically requires post-approval studies for medical devices that receive a PMA, the FDA\u2019s highest level of regulatory approval. FDA post-approval studies use high-quality prospective data to confirm that the clinical study data submitted to the FDA to receive a PMA applies to a broader, real-world population of patients.\n<\/p>\n

\nIn total, Abiomed completed five post-approval studies for Impella over the seven years since its initial PMA was received. This large, multi-center experience was conducted at 46 sites and enrolled a total of 1,833 patients.\n<\/p>\n

\n\u201cThis significant regulatory milestone once again confirms the safety and efficacy of Impella across a variety of clinical indications. I applaud the physician-researchers who led these studies and thank the patients who participated in them,\u201d said Chuck Simonton, MD, Abiomed\u2019s chief medical officer.\n<\/p>\n

\nThe totality of Impella data collected in the U.S., Europe and Japan demonstrates Impella improves outcomes and lowers costs. (see figure 1<\/i>) This data includes:\n<\/p>\n