Abiomed (Nasdaq:ABMD) announced that the FDA accepted and closed its post-approval study reports for its Impella heart pumps.
Danvers, Massachusetts-based Abiomed’s study reports relate to Impella’s premarket approvals (PMA). The company said in a news release that the FDA’s action represents “another affirmation” of the safety and effectiveness of Impella heart pumps.
Impella pumps treat cardiogenic shock, high-risk PCI and post-cardiotomy cardiogenic shock. They also cover cardiogenic shock in the setting of myocarditis or cardiomyopathy and right heart failure.
Abiomed said the FDA typically requires post-approval studies for medical devices under PMA. Post-approval studies use high-quality, prospective data to confirm that clinical study data used for PMA submission applies to a broader real-world patient population.
The company completed five total post-approval studies over seven years since its initial PMA. Its large, multi-center effort spanned 46 sites, enrolling 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,” said Dr. Chuck Simonton, Abiomed’s CMO.
A look at the data supporting Impella
Abiomed collected data across the U.S., Europe and Japan. The company said it demonstrates both the improvement of outcomes and the lowering of costs.
Impella-supported protected percutaneous coronary intervention (PCI) improves quality of life, the company said. It demonstrated a 22% to 45% improvement in left ventricular ejection fraction at 90-day follow up. It also produced a 58% to 80% reduction in New York Heart Association Class III and IV symptoms. Abiomed reported 29% to 47% fewer adverse events at 90 days.
The pump also improves outcomes in cardiogenic shock with 71% to 82% survival with best practice protocols. It demonstrated 90% to 99% native heart recovery in the 2018 to 2020 National Cardiogenic Shock Initiative (NCSI) Study. Abiomed said it saw two-times higher survival for ECMO therapy when combined with Impella unloading (known as ECpella).
Its cost-effectiveness came through in the reduction of hospital length-of-stay to 11 days in elective, urgent and emergent settings. Abiomed said Impella reduces hospital cost per case by $45,000 to $54,000 in coronary artery disease and AMI cardiogenic shock. It provides up to $887,000 in cost savings for each avoidance of a heart transplant or implantable LVAD.