December 2, 2019
FDA Issues Update on Postapproval Study Findings for Abiomed's Impella RP System
December 2, 2019—The FDA issued an update on data for the Impella RP system (Abiomed, Inc.). The most recent, interim postapproval study (PAS) results for the Impella RP System are available on the FDA Post-Approval Studies webpage.
According to the FDA, these latest results continue to show the survival rate for the subgroup of PAS patients who would have met the enrollment criteria for the premarket clinical studies (72.7%, 16 of 22 patients) is similar to the premarket clinical study survival rate (73.3%), while the survival rate for the subgroup of PAS patients who would not have qualified for the premarket clinical studies is lower (13.6%, 6 of 44 patients).
This update follows the FDA’s May 2019 letter to health care providers confirming the device’s safety and efficacy. The next PAS report is due March 20, 2020, and the FDA will continue to publish interim results from the ongoing study on the Post-Approval Studies webpage.
In the United States, the Impella RP device is FDA approved and received European CE Mark approval to treat right heart failure or decompensation after left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. In addition, the CE Mark approval also indicates the Impella RP device for the treatment of refractory ventricular arrhythmia.
In October, Abiomed announced that principal investigators of the National Cardiogenic Shock Initiative study presented new data at a clinical meeting for the management of patients in cardiogenic shock held in Detroit, Michigan. The company’s chart of detailed data is available online here.
Abiomed stated that these real-world outcome data at approximately 2 years show that when physicians followed the FDA’s approved protocol for the Impella RP device, they achieved 72% patient survival and 88% native heart recovery. These results from the Impella RP’s PAS match the survival rate in the device’s preapproval study, noted the company.