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FDA Approves Impella RP Heart Pump
The Impella RP (Right Percutaneous) System has received FDA approval under a humanitarian device exemption (HDE).
The system is the first agency-approved percutaneous single-access heart pump designed for right heart support. The Impella RP device was submitted for FDA review in September 2014 after the completion of the pivotal RECOVER RIGHT trial.
Delivered through a catheter in the leg, the Impella RP system is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients who develop acute right heart failure or decompensation after the implantation of a left ventricular assist device, myocardial infarction (MI), heart transplant, or open-heart surgery. These patients lack blood flow from the right side of their hearts. The Impella RP device is designed to provide the flow and pressure needed to compensate for right heart failure. The system does not require a surgical procedure for insertion, and it provides up to 4 liters per minute of hemodynamic support.
As part of the HDE approval, the system’s developer (Abiomed, Inc.) is required to conduct two post-approval studies. One study will include 30 adults, and the other will involve a maximum of 15 pediatric patients (less than18 years of age) with right ventricular failure (RVF). These trials will be conducted to monitor the post-market safety and probable benefit of the Impella RP device. Both studies will be single-arm multicenter trials that will follow the respective patients at 30 and 180 days after device explant.
The RECOVER RIGHT trial was a prospective, single-arm study designed to evaluate the safety and probable benefit of the Impella RP device in patients with RVF that was refractory to medical treatment and was deemed to require hemodynamic support.
The 30 patients enrolled in the RECOVER RIGHT study comprised two cohorts. Cohort A included patients who developed RVF within 48 hours after the implantation of a left ventricular assist device (LVAD). Cohort B included patients who developed RVF within 48 hours after post-cardiotomy shock or post-acute MI shock. The study’s primary endpoint was patient survival at 30 days, hospital discharge, or the bridge to the next therapy.
The results from this study were announced in October 2014 at the annual Transcatheter Cardiovascular Therapeutics 2014 scientific meeting in Washington, D.C. Overall, the survival rate was 73% in the entire population at 30 days. Cohort A showed a survival rate of 83%, and Cohort B showed a survival rate of 58%.
Source: Abiomed; January 27, 2015.