DANVERS, Mass., March 20, 2014 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced the completion of the 30th patient enrolled in RECOVER RIGHT, an Investigational Device Exemption (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.
"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."
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.
* The Impella RP is currently the subject of an investigational device exemption (IDE) clinical study and is limited by federal law to investigational use.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com
FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.