Abiomed Receives FDA IDE Approval for Use of New Impella RP in Pivotal Clinical Study
DANVERS, Mass., Nov. 12, 2012 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, announced today that it received Investigational Device Exemption (IDE) approval from the Food & Drug Administration (FDA) for the use of the new Impella® RP (Right-side Percutaneous) in a pivotal clinical study in the United States.
The Impella RP is a breakthrough percutaneous heart pump that is implanted through a single access site in the patient's leg and deployed across the right side of the heart without requiring a surgical procedure.
This IDE approval enables the use of the Impella RP in a clinical study called RECOVER RIGHT, led by principal investigators Mark Anderson, M.D., chair of the Division of Cardiothoracic Surgery at Einstein Healthcare Network and William O'Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital. The study, which is expected to begin in early 2013, will enroll 30 patients from ten different hospital sites and is estimated to take up to 24 months to complete. The study will enroll patients that present with signs of right side heart failure, require hemodynamic support and are being treated in the catheterization lab or cardiac surgery suite.
The RECOVER RIGHT study will collect safety and effectiveness data on the percutaneous use of the Impella RP and will be applied towards the submission of a Humanitarian Device Exemption (HDE).
"This FDA IDE approval for our Impella RP is a major milestone for the Company and we look forward to collecting data on this unique patient population with an unmet medical need," said Michael R. Minogue, President, Chairman and Chief Executive Officer, Abiomed.
An HDE is similar to a premarket approval (PMA) application but is intended for patient populations of 4,000 or less per year in the United States. In order to receive an HDE, there must be no comparable devices approved under PMA that are available to treat the targeted population. An approved HDE authorizes sales of the device to any hospital after Institutional Review Board review.
Prior to submitting an HDE, a HUD (Humanitarian Use Device) approval is necessary from the FDA, which Abiomed received on July 13, 2012. The HUD-approved indication for the Impella RP device in this study is "to provide temporary circulatory support for patients in cardiogenic shock, which is due to acute right ventricular failure."
In the future, Abiomed plans to expand its clinical experience with the Impella RP through a pivotal biventricular "Bridge to Recovery" study, in combination with the Impella left-side devices.
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
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This release contains forward-looking statements, including statements regarding expected patient outcomes, 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 anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, 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 Annual Report filed on Form 10-K and most recently filed 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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