The vendor and the FDA believe this might be due to poor patient selection and implanting the device too late to aid the patient. The Impella RP System pumps blood from the inferior vena cava to the pulmonary artery. That persuaded FDA to approve the device but request a post-approval study.Now, FDA has seen early data from the post-approval study.
Voluntary reports can be submitted through • Device manufacturers and user facilities must comply with the applicable The FDA said it will continue to review data from the ongoing PAS and other available data sources as they become available.
Less than one-third of patients in the post-approval study would have met the pre-approval enrollment criteria, for reasons including being in cardiogenic shock for more than 48 hours or suffering in-hospital cardiac arrests. This included post-device explant, hospital discharge (whichever was longer), or to the start of longer-term therapy such as heart transplant or implantation of a surgical right ventricular assist device (RVAD). Press release from MED Michigan Holdings, LLC
Fluoroscopy is required to guide placement of the Impella ® RP Catheter.
The vendor and the FDA believe this might be due to poor patient selection and implanting the device too late to aid the patient.The U.S. Food and Drug Administration (FDA) sent a letter to cardiologists this week to explain its evaluation of high mortality rates reported in the Abiomed Impella RP heart pump post-approval study (PAS).
The free newsletter covering the top industry headlinesThe free newsletter covering the top industry headlines To help guide these decisions Abiomed created an FDA-approved checklist.
Discover announcements from companies in your industry. One interpretation is that the Impella RP System may no longer be used in patients who do not meet the pre-approval study enrollment criteria. That resulted in an interim survival rate of 17%.The 56 percentage point difference between the pre and post-approval survival rates prompted FDA to write to cardiologists and other healthcare professionals. Sixteen of the 23 patients enrolled in the PAS would not have met the enrollment criteria for the premarket clinical studies.Specifically, before getting the Impella RP system implanted, patients in the PAS were more likely than the premarket clinical study patients to have been in cardiogenic shock for longer than 48 hours, experienced an in-hospital cardiac arrest, been treated with an intra-aortic balloon (IABP) pump, or suffered a pre-implant hypoxic or ischemic neurologic event.
Still, the letter spooked investors throwing the stock down 6% on Monday.Abiomed won approval for its Impella RP System in 2017 on strength of data from a study of 60 patients who required temporary right ventricular support as a result of acute right heart failure or decompensation.
The table below shows the statistical differences in the patient characteristics or timing of treatment:The dominant change that was observed in the PAS was prolonged time in shock (more than 24 hours) before placement of the Impella RP device in these patients, Abiomed stated. Abiomed won approval for its Impella RP System in 2017 on strength of data from a study of 60 patients who required temporary right ventricular support as a result of acute right heart failure or decompensation.
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