FDA warns of an increased rate of mortality in patients receiving Abiomed Impella RP System
The FDA is evaluating recent interim post-approval study (PAS) results which suggest a higher mortality rate for patients treated with the Abiomed Impella RP System than the rate previously observed in the premarket clinical studies.
The Impella RP System is a temporary right heart pump system intended to help patients maintain stable heart function without open chest surgery. The FDA wants to ensure you are aware of the mortality rate that has been observed in the ongoing PAS.
Although the FDA is concerned about the high mortality rate from the interim PAS results, we believe 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. Our current analysis of these results and recommendations for healthcare providers who may use the Impella RP System follow below.
The FDA approved the Impella RP System on September 20, 2017. The device is implanted centrally via peripheral access to help patients who require temporary emergency support of right ventricular function. Use of the device, which may be up to 14 days, requires patients to stay in the hospital.
In the premarket clinical studies, where strict inclusion and exclusion criteria were followed, a total of 44 out of 60 patients (73.3 percent) survived to 30 days post device explant or hospital discharge (whichever was longer), or to the start of next longer term therapy, including heart transplant or implantation of a surgical right ventricular assist device (RVAD).
The FDA mandated the firm, Abiomed, to conduct a PAS as a condition of approval for the Impella RP System. The Impella RP PAS will follow 60 newly treated patients for one year through the firm’s cVAD registry. The primary endpoint is survival to 30 days post device explant or hospital discharge (whichever is longer), or to the start of next longer term therapy. Interim results from the most recent PAS report, which reflect device use in a broader patient population, indicate that only 4 out of the 23 enrolled PAS patients (17.4 percent) met the primary survival endpoint.
The FDA required additional analyses from Abiomed, and data submitted by the firm in January 2019 suggest that the high mortality rate observed in the PAS may be primarily related to differences in pre-implant characteristics of the PAS patients compared to the patients in the premarket clinical studies.
