Abiomed Closes Patient Enrollment In Recover Right Impella Study - Quick Facts

(RTTNews) - Abiomed Inc. (ABMD) announced that it has completed the 30th patient Enrollment in Recover Right, an Investigational Device Exemption or IDE study of Impella RP (Right Peripheral). The trial was designed to enroll as many as 30 patients, at 15 sites, for up to 14 days of circulatory support.

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 over 4 liters per minute of hemodynamic support.

The Recover Right clinical study, which commenced after receiving Food & Drug Administration (FDA) IDE approval in November 2012, has enrolled 30 patients, each 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. Data from this IDE study will be utilized to support a Human Device Exemption (HDE) submission to the FDA.

Following the completion of patient enrollment, Abiomed will be submitting the compiled data and seeking approval for a Continuous Access Protocol (CAP) to enable the 15 approved Impella RP sites to continue enrolling a limited number of patients that meet the criteria and protocol.

"We are extremely grateful for the support from the study's principal investigators, Dr. Mark Anderson, at Einstein Medical Center Philadelphia and Dr. William O'Neill at Henry Ford Hospital, as well as the other investigators involved in this trial.....The dedication from these investigators has led to the completion of patient enrollment and will enable data analysis and submission for a HDE with anticipated approval in early 2015," said Michael Minogue, Chairman, President and Chief Executive Officer of Abiomed.