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.
Based in Danvers, Mass., Abiomed's technology focuses on circulatory support .