Abiomed Successfully Completes All Impella Post-Approval Studies for High-Risk PCI, Cardiogenic Shock, Post-Cardiotomy Cardiogenic Shock and Right Heart Failure
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The FDA typically requires post-approval studies for medical devices that receive a PMA, the FDA’s 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.
“This 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,” said
The totality of Impella data collected in the
- Impella-supported Protected PCI improves quality of life, with a 22% to 45% improvement in left ventricular ejection fraction at 90-day follow up1, 2, 3, a 58% to 80% reduction in New York Heart Association Class III and IV symptoms1, 3 and 29% to 47% fewer adverse events at 90 days1, 14.
- Impella improves outcomes in cardiogenic shock, with 71% to 82% survival with best practice protocols5, 15, 17, 90% to 99% native heart recovery in the 2018 to 2020 National Cardiogenic Shock Initiative (NCSI) Study4, 15 and up to two-times higher survival for ECMO therapy when it is combined with Impella unloading (known as ECpella)18.
- Impella is a cost-effective therapy that reduces hospital length-of-stay two to eleven days in elective, urgent and emergent settings7, 8, 9, 10, 11, 12, reduces hospital cost per case by
$45,000to $54,000in coronary artery disease and AMI cardiogenic shock6, 13 and provides up to $887,000in cost savings for each avoidance of a heart transplant or implantable LVAD16.
Impella is the most studied heart pump in the history of the FDA, with studies being conducted from 2006 to the present. Real-world data exists on nearly 200,000 Impella patients (see figures 2 & 3) and Impella is the subject of more than 1,200 peer-reviewed publications. It is included in 13 clinical society guidelines.
The clinical data and best practices learned from all Impella studies performed with the FDA, the
- O’Neill, et al. (2012). Circulation, 126 (14), 1717-1727.
- Burzotta, et al. (2019).
Journal of Interventional Cardiology, 1–10.
- Patel et al. EF Improvement Following Contemporary HRPCI: Restore EF Study. J of SCAI 2022.
- O’Neill, et al. (2020). TCT Connect 2020 Presentation.
- Ako, et al. (2022). TCT Symposium.
- Stretch, et al. (2014). JACC, 64 (14), 1407-15.
- Maini, et al. (2014). Expert Rev Pharmacoecon Outcomes Res, 14 (3), 403-16.
- Gregory, et al. (2013). Am Health Drug Benefits, 6 (2), 88-99.
- Gregory, et al. (2013).
Journal of Managed Care Medicine, 16 (1), 61-69.
- Aryana, et al. (2014). Heart Rhythm, 11 (7), 1122-30.
- Wohns, et al. (2014). Innovations, 9 (1), 38-42.
- Cheung, et al. (2012). J Am Coll Cardiol, 60 (17 Suppl B) B110. Abstract TCT-385.
- Silver, et al. (2017). Nephron, 137 (4), 297–301.
- Dangas, et al. (2014). Am J Cardiol, 113 (2), 222-8.
- Basir, et al. (2021). SCAI Scientific Sessions.
- Milliman. (2017). US Organ and Tissue Transplant Cost Estimates and Discussion.
- Tehrani, et al. (2019). JACC, 73 (13), 1659-69.
- Pappalardo, et al. (2017). Eur J Heart Fail, 19 (3), 404-412.
ABOUT IMPELLA HEART PUMPS
Impella CP with SmartAssist® is
Impella CP with SmartAssist® and Impella 5.5® with SmartAssist® are
Impella RP® with SmartAssist is
Any forward-looking statements are subject to risks and uncertainties such as those described in
For further information:
+1 (978) 882-8491
Executive Vice President and Chief Financial Officer
+1 (978) 646-1680