DANVERS, Mass., May 21, 2014 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced it has received approval for implementation of a Continuous Access Protocol (CAP) from the Food & Drug Administration (FDA) for RECOVER RIGHT, an Investigational Device Exemption (IDE) study of the Impella® RP (Right Peripheral) System. The CAP will allow Abiomed to continue enrolling up to 22 additional patients at the 15 U.S. investigational sites for a six month period.
In March 2014, 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 this IDE study will be utilized to support a Human Device Exemption (HDE) submission.
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.
* The Impella RP is currently the subject of an investigational device exemption (IDE) clinical study and is limited by federal law to investigational use.
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
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.
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