Abiomed Crosses a Huge Hurdle with Heart Pumps
There’s more regulatory activity surrounding Abiomed’s heart pumps. The Danvers, MA-based company noted that FDA […]
Abiomed said FDA’s action is another affirmation that the Impella heart pumps are safe and effective for cardiogenic shock, high-risk PCI, postcardiotomy 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
Original Article: (https://www.mddionline.com/cardiovascular/abiomed-crosses-huge-hurdle-heart-pumps)
