The study, which received FDA approval in October 2016, is a prospective, multi-center feasibility study led by principal investigators Dr. Navin K. Kapur of Tufts Medical Center and Dr. William W. O'Neill of Henry Ford Medical Center. Up to 50 patients at 10 sites will be enrolled in the study, which is expected to be completed within 18 months.
The first patient in the study was enrolled in late April at Northwell Health System in Long Island, NY under the leadership of Dr. Perwaiz Meraj.
The primary endpoints of the feasibility study will focus on safety, including Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days. All patients will undergo cardiac magnetic resonance (CMR) imaging to assess infarct size as percent of left ventricular mass at 30 days post-PCI. Patients will be randomized to Impella CP placement with immediate primary PCI, or to Impella CP placement with 30 minutes of unloading prior to primary PCI. The hypothesis of this novel approach to treating STEMI patients, based on extensive mechanistic research, is that unloading the left ventricle prior to PCI reduces myocardial work load, oxygen demand and also initiates a cardio-protective effect at the myocardial cell level, which may alleviate myocardial damage caused by reperfusion injury at the time of revascularization. This feasibility study will help refine the protocol and lay the groundwork for a future pivotal study with more sites, patients and will be designed for statistical significance. Abiomed does not plan to announce additional enrollment status.
The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella CP, Impella 5.0, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries. cVAD Registry is a trademark of ABIOMED, Inc.
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.
For further information please contact:
Ingrid Goldberg
Director, Investor Relations
978-646-1590
igoldberg@abiomed.com
Adrienne Smith
Senior Director, Public Relations and Corporate Communications
978-646-1553
adsmith@abiomed.com
SOURCE : Abiomed
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