FDA Accepts and Closes Impella® Post-Approval Studies for Major Indications

Chuck Simonton, MD, Chief Medical Officer at Abiomed, reviews that in October 2022 the FDA accepted and closed all Impella post-approval studies that Abiomed has conducted for the major indications for Impella® which were all issued in 2015-2016 timeframe:

• High-risk PCI
• Cardiogenic shock
• Post-cardiotomy cardiogenic shock
• Right heart failure

A press release by Abiomed states, “The FDA’s action is another affirmation that 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.” It also states, “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.”

Dr. Simonton explains that this data, along with other investigator-initiated and Abiomed-sponsored studies, tells us that Impella® improves outcomes and lowers costs by improving quality of life in high-risk PCI, improving outcomes and survival in cardiogenic shock and providing cost-effective therapy that reduces hospital length of stay. The data also indicates that Impella provides cost-effective therapy that reduces hospital length of stay, hospital costs and provides cost savings for each avoidance of heart transplant or implantable LVAD.

Dr. Simonton also emphasizes that Abiomed is continuing to look at real-world clinical data from the ongoing Impella Quality (IQ) registry database and cVAD (USpella) study “to learn more and more about these patients and how they can benefit from Impella.” He highlights the upcoming randomized trials:

• PROTECT IV RCT in high-risk PCI
• STEMI DTU RCT in patients with non-shock acute ST elevation MI
• RECOVER IV RCT in cardiogenic shock

“These randomized trials are built on all this data I just showed you,” Simonton concludes, “which has developed best practices for our patients going forward.”