Abiomed, a provider of heart support technologies, has received approval for implementation of a Continuous Access Protocol (CAP) from the US Food Drug Administration (FDA) for Recover Right, an Investigational Device Exemption (IDE) study of the Impella RP (right peripheral) system.
The CAP will allow Abiomed to continue enrolling up to 22 additional patients at the 15 US investigational sites for a six month period.
In March 2014, the Recover Right trial completed its enrollment of the required 30 patients, all of whom presented with signs of right side heart failure, required hemodynamic support, and were treated in either a catheterization lab, hybrid lab or cardiac surgery suite.
The data from the 30 patients enrolled in this IDE study will be utilized to support a Human Device Exemption (HDE) submission.
The Impella RP is a percutaneous heart pump that is implanted through a single access site in the patient’s leg and deployed through the venous system, across the right side of the heart. The device does not require a surgical procedure for insertion, and it provides up to four liters per minute of hemodynamic support.