Abiomed (NSDQ:ABMD) said the FDA will allow it to nearly double enrollment in a clinical trial of its Impella RP right-side heart pump, the Recover Right study, as it seeks a humanitarian device exemption from the watchdog agency.
The Recover Right trial is designed to track Impella RP patients for 14 days. Like Abiomed’s flagship Impella heart pump, the Impella RP is threaded into the heart via the femoral artery in the thigh. But unlike previous Impella models, all designed for the heart’s left ventricle, the Impella RP is designed to access the heart’s right ventricle via the vena cava.
The Danvers, Mass.-based medical device company met the 30-patient enrollment goal for the study in March, saying at the time that it planned to ask the FDA for permission to enroll more patients. Today Abiomed said the FDA approved a continuous access protocol for the Recover Right trial that will allow Abiomed to enroll up 22 more subjects over 6 months.
Abiomed won an investigation device exemption from the FDA for the Recover Right trial in 2012, implanting the 1st patient in the spring of 2013. To be eligible for the 2-year study, patients must either develop right-side heart failure within 48 hours after LVAD implantation, after going into shock within 48 hours of heart surgery or after a heart attack.
The Impella RP won CE Mark approval in the European Union last month.