Abiomed has announced that the patient enrollment in the RECOVER RIGHT Impella study has been completed with the 30th patient enrolled in the study.
The Investigational Device Exemption (IDE) study of Impella (right peripheral) has been designed to enroll 30 patients, at 15 sites, for up to 14 days of circulatory support.
With the completion of patient enrollment, Abiomed will be submitting the compiled data and seeking approval for a continuous access protocol to enable the 15 approved Impella RP sites to continue enrolling a limited number of patients that meet the criteria and protocol.
The US Food and Drug Administration has approved IDE approval to Abiomed for the RECOVER RIGHT clinical study in November 2012. The study 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.
Abiomed will use data from this IDE study to support a Human Device Exemption submission to the FDA.
Abiomed chairman, president and CEO Michael Minogue noted the company is 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," Minogue added.
The percutaneous heart pump, which does not require a surgical procedure for insertion, 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 provides over four liters per minute of hemodynamic support.