Continuous Access Protocol Granted for Study of Abiomed's Impella RP System

May 21, 2014­—Abiomed, Inc. announced it has received US Food and Drug Administration (FDA) approval for implementation of a Continuous Access Protocol (CAP) for the RECOVER RIGHT 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 investigational sites in the United States for a 6-month period.

According to the company, the RECOVER RIGHT trial completed its enrollment of the required 30 patients in March 2014. All 30 patients presented with signs of right side heart failure, required hemodynamic support, and were treated in a catheterization lab, hybrid lab, or cardiac surgery suite. RECOVER RIGHT is being conducted under an FDA investigational device exemption (IDE). The data from the 30 patients enrolled in this IDE study will be utilized to support a human device exemption (HDE) submission to the FDA.

The Impella RP is a percutaneous heart pump that provides up to 4 liters per minute of hemodynamic support. The device 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 Impella RP is currently limited by federal law to investigational use, advised Abiomed.