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The Danvers, MA-based company said FDA has accepted and closed post-approval studies for the Impella heart pumps.
Omar Ford
October 23, 2022
2 Min Read
Image courtesy of PIXDUCE / Alamy Stock Photo
There’s more regulatory activity surrounding Abiomed’s heart pumps. The Danvers, MA-based company noted that FDA closed the post-approval studies related to the PMAs for the Impella Heart Pumps.
Abiomed said FDA’s action is another affirmation that the 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.
In 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.
“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,” Chuck Simonton, MD, Abiomed’s CMO said in a release.
Study data includes:
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 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 $45,000 to $54,000 in coronary artery disease and AMI cardiogenic shock6, 13 and provides up to $887,000 in cost savings for each avoidance of a heart transplant or implantable LVAD16.
The post-study approvals come on the heels of a strong showing from Abiomed at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 Conference held last month. MD+DI highlighted Abiomed’s accomplishments in a report titled 6 Big Developments Coming Out of TCT.
The post-study also occurs a few days after Abiomed received FDA clearance for its Impella low-profile sheath.
Abiomed is set to report on its 3Q22 earnings on November 1st.
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