We’ve followed Abiomed, Inc. for a while, most recently covering the news that its Impella heart pump family had driven sales to 21% year on year growth. Now the company has issued a press release announcing the completion of the target of 30 patients enrolled in RECOVER RIGHT, an Investigational Device Exemption (IDE) study of Impella® RP (Right Peripheral).
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 was designed to enroll as many as 30 patients, at 15 sites, for up to 14 days of circulatory support. Each patient presented with signs of right side heart failure, requiring hemodynamic support, and were treated in either a catheterization lab, hybrid lab or cardiac surgery suite.
Upon this 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.
Data from this IDE study will be utilized to support a Human Device Exemption (HDE) submission to the FDA.
“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,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “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.”
Source: Abiomed, Inc., Globe Newswire