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# FDA Nixes Post-marketing Requirements on Impella Pumps
- URL: https://www.fdaweb.com/fda-nixes-post-marketing-requirements-on-impella-pumps/
- Published: 2022-10-20T12:00:00.000Z
- Updated: 2026-09-14T18:03:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153020

FDA has closed its post-approval study requirements for Abiomed PMA for its [Impella heart pumps](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.heartrecovery.com%2Fproducts-and-services%2Fimpella&esheet=52949141&newsitemid=20221020005716&lan=en-US&anchor=Impella+heart+pumps&index=2&md5=f8172e3bfea3f1fcfd29e075f4993065&ref=fdaweb.com). As a result, the company says the agency has affirmed that the pumps are safe and effective for cardiogenic shock, high-risk percutaneous coronary intervention (PCI), post-cardiotomy cardiogenic shock, cardiogenic shock in the setting of myocarditis or cardiomyopathy, and right heart failure.

Overall, Abiomed says it completed five post-approval studies for Impella over the seven years since its initial PMA was received, which included 46 sites and 1,833 patients. Data show that Impella-supported PCI improves quality of life with a 22% to 45% improvement in left ventricular ejection fraction at a 90-day follow up, a 58% to 80% reduction in New York Heart Association Class III and IV symptoms, and 29% to 47% fewer adverse events at 90 days, it says. And data also showed that Impella’s use in cardiogenic shock resulted in 71% to 82% survival, and 90% to 99% native heart recovery.

“Impella is the most studied heart pump in the history of the FDA, with studies being conducted from 2006 to the present,” Abiomed says. “Real-world data exists on nearly 200,000 Impella patients … and Impella is the subject of more than 1,200 peer-reviewed publications,” it says, adding that the pumps are included in 13 clinical society guidelines.