Post-market study of Impella RP system reports survival rates in heart failure

Abiomed has announced survival data from the 18 month post-approval study of 42 Impella RP patients with heart failure. The new post-approval study data finds survival rates of 64% (9/14) for the Recover Right Protocol Population (N=14) and 11% (3/28) for Salvage Patient Population (N=28). This compares with data from the Pre-market Approval (PMA) Study Results which showed 73% (44/60) survival rate in PMA Subjects full cohort (N=60), 77% (24/31) for Cohort A – LVAD Patients (N=31) and 69% (20/29) for Cohort B – Shock Patients (N=29). The latter data was presented in the Journal of Heart and Lung Transplant, December 2018.

The Impella RP post-approval study data compares to a survival rate of 73% in the Impella RP PMA Study, 42% for surgically implanted CentriMag RVAS HDE study protocol, and 29% - 42% self-reported survival to transfer or discharge for adult cardiac ECMO patients. The Impella RP is the only percutaneous technology with FDA PMA approval for right heart support designated safe and effective. Data were presented at the American College of Cardiology’s 68th Annual Scientific Session.

Comment: The Impella 2.5 and Impella CP devices are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD are FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella RP is FDA approved to treat right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.