Press release from GlobeNewswire (a Nasdaq OMX company)
Abiomed Announces First Impella RP Patient Enrolled in Recover Right Study
Monday, April 01, 2013
Abiomed Announces First Impella RP Patient Enrolled in Recover Right Study05:00 EDT Monday, April 01, 2013
DANVERS, Mass., April 1, 2013 (GLOBE NEWSWIRE) -- Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today announced the enrollment of the first patient 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 without requiring a surgical procedure.
The RECOVER RIGHT clinical study, which received FDA IDE approval to begin in November 2012, will enroll 30 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 following two patient cohorts will be examined in the RECOVER RIGHT study:
1) Patients that develop right side heart failure within 48 hours post-left ventricular assist device (LVAD) implantation;
2) Patients that develop right side heart failure subsequent to post-cardiotomy shock within 48 hours post surgery or post myocardial infarction.
The first enrollment in the RECOVER RIGHT study was a patient who developed right ventricular dysfunction after receiving an implantable LVAD. The Impella RP was implanted at Einstein Medical Center Philadelphia under the leadership of Mark Anderson, M.D., FACS, Chair of the Division of Cardiothoracic Surgery at Einstein. The Impella RP implant was performed by Christian Witzke, M.D., Director of the Structural Heart Disease Program and Parul Patel, MD., Director of the Cardiac Catheterization Laboratory at Einstein Medical Center Philadelphia.
"This is another example of how Einstein Healthcare Network is committed to providing the best possible outcomes for patients by conducting clinical trials to assess the safety and probable benefit of innovative technologies such as the Impella RP pump," added Dr. Anderson, who is co-principal investigator of the RECOVER RIGHT study with William O'Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital.
"The Impella RP gave this patient a level of hemodynamic support that allowed our heart failure team to treat the patient's right-sided heart failure quickly in a minimally invasively manner," said Dr. Witzke.
The Impella RP is currently the subject of an investigational device exemption (IDE) clinical study and is not currently approved for sale in the United States.
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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