The U.S. Food and Drug Administration (FDA) has shared updated recommendations for the use of Abiomed’s Impella RP System after reviewing final post-approval study (PAS) results. Those recommendations are reflected in the agency’s new labeling for the device.
Context on the Impella RP System
After the FDA approved the Impella RP System for right-sided heart failure back in 2017, it required Abiomed to conduct a PAS to confirm the solution was safe and effective among a real-world patient population. Early results from that PAS, however, concerned the FDA due to a mortality rate that was much higher than had been seen in the premarket research. The key difference, it now turns out, was that the PAS included patients a wider range of patients than the premarket studies had—and it was those newly included patients who were not a safe fit for the Impella RP.
For example, among PAS patients who would have been included in the earlier premarket studies, the Impella RP System was associated with a survival rate of 69.7%. However, among PAS patients who would not have been eligible for the earlier premarket studies, the survival rate was just 18.6%.
“PAS patients who would not have qualified for the premarket clinical studies were more likely to have been in acute right heart failure or decompensation for longer than 48 hours and experienced a severe cardiogenic shock, end organ failure or acute neurologic injury, compared to the PAS patients who would have met the enrollment criteria for the premarket clinical studies,” the FDA explained in its updated analysis.
The FDA’s updates on the Impella RP
The FDA has updated the Impella RP System’s labeling to better reflect this improved understanding of its safety and effectiveness. The labeling now emphasizes it is not indicated for patients with acute right heart failure or decompensation that has lasted longer than 48 hours or those who present with “profound shock, end organ failure or acute neurologic injury.”
“The FDA believes that when the device is used for the currently approved indication in appropriately selected patients the benefits of the Impella RP System continue to outweigh the risks,” the agency said.
The FDA recommends that healthcare providers review these changes and discuss the benefits and risks of treatment with all patients. Any adverse events that may be linked to the Impella RP System should be reported to the agency.
And what does Abiomed think about the FDA updates?
"We are excited about the indication change, which aligns with best practices and how Abiomed has been training physicians to use Impella RP for several years," the company said in a statement.
Read more here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.