Abiomed Announces First Patient Enrolled in STEMI DTU Feasibility Study
(Thomson Reuters ONE) -
DANVERS, Mass., May 04, 2017 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a
leading provider of breakthrough heart support technologies, announced today the
enrollment of the first patient in the Food and Drug Administration (FDA)
approved prospective feasibility study, STEMI Door to Unloading (DTU) with
Impella CP® system in acute myocardial infarction. This trial will focus on
feasibility and safety of unloading the left ventricle using the Impella CP
heart pump prior to primary percutaneous coronary intervention (PCI) in patients
presenting with ST segment elevation myocardial infarction (STEMI) without
cardiogenic shock with the hypothesis that this will potentially reduce infarct
size.
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(at)abiomed.com
Adrienne Smith
Senior Director, Public Relations and Corporate Communications
978-646-1553
adsmith(at)abiomed.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Abiomed via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 04.05.2017 - 13:01 Uhr
Sprache: Deutsch
News-ID 540357
Anzahl Zeichen: 5430
contact information:
Town:
Danvers
Kategorie:
Business News
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