The FDA granted Abiomed a Humanitarian Device Exemption approval for the company’s Impella RP (Right Percutaneous) System. This is the first FDA approved percutaneous single access heart pump that’s intended for supporting the right side of the heart. It is capable of augmenting by up to four liters of blood per minute and is indicated to be used for up to 14 days in both adult and pediatric patients that “develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery,” according to Abiomed.
The company will be rolling out the device under close supervision, first bringing to its offices cardiac teams from hospitals that will be offering the Impella RP in order to receive appropriate training. These include cardiac surgeons, interventional cardiologists, heart failure cardiologists, and lead nurses.
More about the approval and the clinical trial results that led to it:
As part of the HDE approval, Abiomed is required to conduct two post approval studies (PAS) for the RECOVER RIGHT. One includes an adult patient population of 30 patients and the other, a pediatric patient population for a maximum of 15 patients (larger patients < 18 years of age with RVF.) These studies will be conducted to monitor the post-market safety and probable benefit of the Impella RP device. Both studies will be a single-arm multicenter studies that will follow the respective patients at 30 and 180 days post device explant.
RECOVER RIGHT was an FDA-approved, prospective, multicenter, single arm study designed to evaluate the safety and probable benefit of the Impella RP in patients with right ventricular failure (RVF) refractory to medical treatment and deemed to require hemodynamic support.
The 30 patients enrolled in the RECOVER RIGHT trial were categorized into two patient cohorts. Cohort A included patients who developed RVF within 48 hours after implantation of a left ventricular assist device (LVAD). Cohort B examined patients who developed RVF within 48 hours of post-cardiotomy shock or post-acute myocardial infarction (AMI) shock. The primary endpoint was patient survival at 30 days, hospital discharge, or bridge to the next therapy.
The clinical trial results from RECOVER RIGHT were announced in October 2014 at the annual Transcatheter Cardiovascular Therapeutics (TCT) 2014 scientific meeting in Washington, DC. Overall, the survival rate was 73% in the entire population at 30 days. Cohort A showed a survival rate of 83.3% and Cohort B showed a 58.3% survival rate at 30 days.
Press release: Abiomed Receives FDA HDE Approval for the Impella RP…