FDA OKs Expanded Enrollment for Abiomed’s Impella RP Trial

Abiomed Inc. has received U.S. Food and Drug Administration (FDA) approval for implementation of a continuous access protocol (CAP) “Recover Right,” an investigational device exemption (IDE) study of the company’s Impella RP (right peripheral) system. The CAP will allow Abiomed to continue enrolling up to 22 additional patients at the 15 U.S. investigational sites for a six month period.

In March, 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 the IDE study will be used to support a humanitarian device exemption submission to the FDA.

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 4 liters per minute of hemodynamic support, according to the company.